Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82525

191 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 15, 2019
Product types
Device
Classifications
Class I
Statuses
Completed
Recalling firm wording
Medtronic Vascular

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

191 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use

Z-2562-2019
Recall number
Z-2562-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1226 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN 00613994824059 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 2 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use

Z-2563-2019
Recall number
Z-2563-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
658 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN 00643169013520 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 3 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use

Z-2564-2019
Recall number
Z-2564-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
538 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823823 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 4 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use

Z-2565-2019
Recall number
Z-2565-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823779 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 5 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use

Z-2566-2019
Recall number
Z-2566-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823762 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 6 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use

Z-2567-2019
Recall number
Z-2567-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824028 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 7 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use

Z-2568-2019
Recall number
Z-2568-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823960 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 8 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use

Z-2569-2019
Recall number
Z-2569-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1491 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823922 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 9 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use

Z-2570-2019
Recall number
Z-2570-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
655 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823908 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 10 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use

Z-2571-2019
Recall number
Z-2571-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1701 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823892 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 11 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular use

Z-2572-2019
Recall number
Z-2572-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
221 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823878 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 12 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular use

Z-2573-2019
Recall number
Z-2573-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823441 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 13 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use

Z-2574-2019
Recall number
Z-2574-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823427 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 14 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use

Z-2575-2019
Recall number
Z-2575-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823359 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 15 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use

Z-2576-2019
Recall number
Z-2576-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823588 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 16 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use

Z-2577-2019
Recall number
Z-2577-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823571 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 17 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use

Z-2578-2019
Recall number
Z-2578-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823519 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 18 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use

Z-2579-2019
Recall number
Z-2579-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824660 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 19 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovascular use

Z-2580-2019
Recall number
Z-2580-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824226 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 20 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use

Z-2581-2019
Recall number
Z-2581-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
215 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824172 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 21 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascular use

Z-2582-2019
Recall number
Z-2582-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824127 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 22 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use

Z-2583-2019
Recall number
Z-2583-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
555 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824080 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 23 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use

Z-2584-2019
Recall number
Z-2584-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
53 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824066 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 24 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use

Z-2585-2019
Recall number
Z-2585-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824042 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 25 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use

Z-2586-2019
Recall number
Z-2586-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824424 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 26 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular use

Z-2587-2019
Recall number
Z-2587-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824288 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 27 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use

Z-2588-2019
Recall number
Z-2588-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822222 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 28 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use

Z-2589-2019
Recall number
Z-2589-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822185 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 29 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 90CM, 070", REF SA6JL40D. for cardiovascular use

Z-2590-2019
Recall number
Z-2590-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822178 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 30 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascular use

Z-2591-2019
Recall number
Z-2591-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822451 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 31 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use

Z-2592-2019
Recall number
Z-2592-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822314 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 32 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use

Z-2593-2019
Recall number
Z-2593-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822307 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 33 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use

Z-2594-2019
Recall number
Z-2594-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822291 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 34 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use

Z-2595-2019
Recall number
Z-2595-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821676 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 35 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use

Z-2596-2019
Recall number
Z-2596-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821959 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 36 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular use

Z-2597-2019
Recall number
Z-2597-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821881 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 37 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use

Z-2598-2019
Recall number
Z-2598-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823076 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 38 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use

Z-2599-2019
Recall number
Z-2599-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823021 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 39 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use

Z-2600-2019
Recall number
Z-2600-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823014 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 40 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use

Z-2601-2019
Recall number
Z-2601-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823007 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 41 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use

Z-2602-2019
Recall number
Z-2602-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
172 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822987 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 42 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use

Z-2603-2019
Recall number
Z-2603-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822970 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 43 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use

Z-2604-2019
Recall number
Z-2604-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822901 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 44 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular use

Z-2605-2019
Recall number
Z-2605-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823267 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 45 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular use

Z-2606-2019
Recall number
Z-2606-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
49 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823250 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 46 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular use

Z-2607-2019
Recall number
Z-2607-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822819 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 47 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use

Z-2608-2019
Recall number
Z-2608-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822772 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 48 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovascular use

Z-2609-2019
Recall number
Z-2609-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822765 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 49 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use

Z-2610-2019
Recall number
Z-2610-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
246 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823816 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 50 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use

Z-2611-2019
Recall number
Z-2611-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823724 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 51 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular use

Z-2612-2019
Recall number
Z-2612-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821843 All Lot Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 52 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use

Z-2613-2019
Recall number
Z-2613-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822796 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 53 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use

Z-2614-2019
Recall number
Z-2614-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822789 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 54 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. for cardiovascular use

Z-2615-2019
Recall number
Z-2615-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6871 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823540 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 55 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use

Z-2616-2019
Recall number
Z-2616-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
8966 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822208 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 56 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use

Z-2617-2019
Recall number
Z-2617-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
32484 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN:00613994823595 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 57 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use

Z-2618-2019
Recall number
Z-2618-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
15603 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN:00613994822338 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 58 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use

Z-2619-2019
Recall number
Z-2619-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6219 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN:00613994822246 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 59 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0, .070", REF SA6JL30. for cardiovascular use

Z-2620-2019
Recall number
Z-2620-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
524 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN:00613994822260 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 60 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for cardiovascular use

Z-2621-2019
Recall number
Z-2621-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
7839 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN:00613994823526 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 61 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU30. for cardiovascular use

Z-2622-2019
Recall number
Z-2622-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
2607 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823625 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 62 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use

Z-2623-2019
Recall number
Z-2623-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823731 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 63 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use

Z-2624-2019
Recall number
Z-2624-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3302 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823786 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 64 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH. for cardiovascular use

Z-2625-2019
Recall number
Z-2625-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
152 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823717 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 65 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use

Z-2626-2019
Recall number
Z-2626-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
614 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823564 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 66 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use

Z-2627-2019
Recall number
Z-2627-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
167 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824769 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 67 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, .070", REF SA6JR40SH. for cardiovascular use

Z-2628-2019
Recall number
Z-2628-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3058 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821850 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 68 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular use

Z-2629-2019
Recall number
Z-2629-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
303 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823496 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 69 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use

Z-2630-2019
Recall number
Z-2630-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821829 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 70 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use

Z-2631-2019
Recall number
Z-2631-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
531 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822499 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 71 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070", REF SA6JR50. for cardiovascular use

Z-2632-2019
Recall number
Z-2632-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
339 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821805 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 72 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. for cardiovascular use

Z-2633-2019
Recall number
Z-2633-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
496 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824639 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 73 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.5, .070", REF SA6SL35. for cardiovascular use

Z-2634-2019
Recall number
Z-2634-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
2818 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822529 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 74 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 .070", REF SA6MAC30. for cardiovascular use

Z-2635-2019
Recall number
Z-2635-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
206 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821720 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 75 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for cardiovascular use

Z-2636-2019
Recall number
Z-2636-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823045 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 76 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use

Z-2637-2019
Recall number
Z-2637-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822574 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 77 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0 SH, .070", REF SA6AL10SH. for cardiovascular use

Z-2638-2019
Recall number
Z-2638-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823755 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 78 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for cardiovascular use

Z-2639-2019
Recall number
Z-2639-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
573 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823953 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 79 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. for cardiovascular use

Z-2640-2019
Recall number
Z-2640-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824608 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 80 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use

Z-2641-2019
Recall number
Z-2641-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1479 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823977 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 81 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5 SH, .070", REF SA6JL35SH. for cardiovascular use

Z-2642-2019
Recall number
Z-2642-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
213 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822215 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 82 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. for cardiovascular use

Z-2643-2019
Recall number
Z-2643-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
1495 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822390 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 83 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5 SH, .070", REF SA6JR35SH. for cardiovascular use

Z-2644-2019
Recall number
Z-2644-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
353 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822352 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 84 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use

Z-2645-2019
Recall number
Z-2645-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
248 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822918 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 85 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. for cardiovascular use

Z-2646-2019
Recall number
Z-2646-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
492 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821966 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 86 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for cardiovascular use

Z-2647-2019
Recall number
Z-2647-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
121 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821874 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 87 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use

Z-2648-2019
Recall number
Z-2648-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
136 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822437 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 88 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT SH .070", REF SA63DRIGHTSH. for cardiovascular use

Z-2649-2019
Recall number
Z-2649-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
87 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823793 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 89 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for cardiovascular use

Z-2650-2019
Recall number
Z-2650-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
305 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821713 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 90 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use

Z-2651-2019
Recall number
Z-2651-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
159 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822963 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 91 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardiovascular use

Z-2652-2019
Recall number
Z-2652-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
237 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822093 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 92 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2, .070", REF SA6MB2. for cardiovascular use

Z-2653-2019
Recall number
Z-2653-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821928 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 93 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for cardiovascular use

Z-2654-2019
Recall number
Z-2654-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823410 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 94 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular use

Z-2655-2019
Recall number
Z-2655-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
117 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823366 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 95 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use

Z-2656-2019
Recall number
Z-2656-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
69 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824615 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 96 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1. for cardiovascular use

Z-2657-2019
Recall number
Z-2657-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
746 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821904 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 97 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0, .070", REF SA6JL50. for cardiovascular use

Z-2658-2019
Recall number
Z-2658-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
567 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822079 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 98 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use

Z-2659-2019
Recall number
Z-2659-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
208 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994842381 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 99 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use

Z-2660-2019
Recall number
Z-2660-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
409 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823809 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 100 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use

Z-2661-2019
Recall number
Z-2661-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
49 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822253 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 101 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0, .070", REF SA6JR30. for cardiovascular use

Z-2662-2019
Recall number
Z-2662-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
102 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822413 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 102 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2 SH, .070", REF SA6MB2SH. for cardiovascular use

Z-2663-2019
Recall number
Z-2663-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821911 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 103 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascular use

Z-2664-2019
Recall number
Z-2664-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
406 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822123 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 104 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use

Z-2665-2019
Recall number
Z-2665-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822444 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 105 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.0 SH, .070", REF SA6EBU30SH. for cardiovascular use

Z-2666-2019
Recall number
Z-2666-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
129 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823601 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 106 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. for cardiovascular use

Z-2667-2019
Recall number
Z-2667-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822932 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 107 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use

Z-2668-2019
Recall number
Z-2668-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
488 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823540 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 108 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardiovascular use

Z-2669-2019
Recall number
Z-2669-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
76 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823069 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 109 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR405. for cardiovascular use

Z-2670-2019
Recall number
Z-2670-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
615 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 20613994822325 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 110 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0, .070", REF SA6SAL10. for cardiovascular use

Z-2671-2019
Recall number
Z-2671-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
191 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823199 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 111 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070", REF SA6AL30SH. for cardiovascular use

Z-2672-2019
Recall number
Z-2672-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824011 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 112 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1 SH, .070", REF SA6MB1SH. for cardiovascular use

Z-2673-2019
Recall number
Z-2673-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
97 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821942 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 113 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070", REF SA6ERADLLT. for cardiovascular use

Z-2674-2019
Recall number
Z-2674-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824752 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 114 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. for cardiovascular use

Z-2675-2019
Recall number
Z-2675-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
185 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821768 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 115 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. for cardiovascular use

Z-2676-2019
Recall number
Z-2676-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822055 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 116 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070", REF SA6SCR35. for cardiovascular use

Z-2677-2019
Recall number
Z-2677-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822611 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 117 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL4.0, .070", REF SA6AL40. for cardiovascular use

Z-2678-2019
Recall number
Z-2678-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824004 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 118 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use

Z-2679-2019
Recall number
Z-2679-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
219 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823687 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 119 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiovascular use

Z-2680-2019
Recall number
Z-2680-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
82 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824165 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 120 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use

Z-2681-2019
Recall number
Z-2681-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822857 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 121 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use

Z-2682-2019
Recall number
Z-2682-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822468 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 122 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use

Z-2683-2019
Recall number
Z-2683-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824134 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 123 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use

Z-2684-2019
Recall number
Z-2684-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
163 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823946 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 124 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use

Z-2685-2019
Recall number
Z-2685-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823274 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 125 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use

Z-2686-2019
Recall number
Z-2686-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822086 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 126 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070", REF SA6MAC375. for cardiovascular use

Z-2687-2019
Recall number
Z-2687-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822048 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 127 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use

Z-2688-2019
Recall number
Z-2688-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
247 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821775 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 128 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for cardiovascular use

Z-2689-2019
Recall number
Z-2689-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823939 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 129 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use

Z-2690-2019
Recall number
Z-2690-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822475 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 130 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use

Z-2691-2019
Recall number
Z-2691-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823397 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 131 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use

Z-2692-2019
Recall number
Z-2692-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824813 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 132 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. for cardiovascular use

Z-2693-2019
Recall number
Z-2693-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824141 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 133 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use

Z-2694-2019
Recall number
Z-2694-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821737 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 134 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use

Z-2695-2019
Recall number
Z-2695-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823403 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 135 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070", REF SA6JL60SH. for cardiovascular use

Z-2696-2019
Recall number
Z-2696-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
37 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822420 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 136 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use

Z-2697-2019
Recall number
Z-2697-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823151 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 137 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for cardiovascular use

Z-2698-2019
Recall number
Z-2698-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822956 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 138 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiovascular use

Z-2699-2019
Recall number
Z-2699-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824776 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 139 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardiovascular use

Z-2700-2019
Recall number
Z-2700-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823700 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 140 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular use

Z-2701-2019
Recall number
Z-2701-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823342 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 141 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use

Z-2702-2019
Recall number
Z-2702-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824158 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 142 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR1.0, .070", REF SA6SAR10. for cardiovascular use

Z-2703-2019
Recall number
Z-2703-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822659 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 143 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL3.5, .070", REF SA6JCL35. for cardiovascular use

Z-2704-2019
Recall number
Z-2704-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824387 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 144 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use

Z-2705-2019
Recall number
Z-2705-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823182 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 145 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use

Z-2706-2019
Recall number
Z-2706-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822895 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 146 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for cardiovascular use

Z-2707-2019
Recall number
Z-2707-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822024 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 147 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use

Z-2708-2019
Recall number
Z-2708-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822666 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 148 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular use

Z-2709-2019
Recall number
Z-2709-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823168 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 149 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use

Z-2710-2019
Recall number
Z-2710-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823052 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 150 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.5, .070", REF SA6MAC45. for cardiovascular use

Z-2711-2019
Recall number
Z-2711-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822000 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 151 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use

Z-2712-2019
Recall number
Z-2712-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
113 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823205 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 152 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0 SH, .070", REF SA6JR50SH. for cardiovascular use

Z-2713-2019
Recall number
Z-2713-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
105 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821799 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 153 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for cardiovascular use

Z-2714-2019
Recall number
Z-2714-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824837 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 154 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular use

Z-2715-2019
Recall number
Z-2715-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821782 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 155 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. for cardiovascular use

Z-2716-2019
Recall number
Z-2716-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824196 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 156 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use

Z-2717-2019
Recall number
Z-2717-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823748 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 157 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, SHORT TIP, .070", REF SA6ERADLST. for cardiovascular use

Z-2718-2019
Recall number
Z-2718-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824721 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 158 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40. for cardiovascular use

Z-2719-2019
Recall number
Z-2719-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822598 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 159 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use

Z-2720-2019
Recall number
Z-2720-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823113 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 160 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use

Z-2721-2019
Recall number
Z-2721-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822406 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 161 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F FR3.5, .070", REF SA6FR35. for cardiovascular use

Z-2722-2019
Recall number
Z-2722-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824202 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 162 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use

Z-2723-2019
Recall number
Z-2723-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823144 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 163 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT, .070", REF SA6ERADR. for cardiovascular use

Z-2724-2019
Recall number
Z-2724-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824707 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 164 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use

Z-2725-2019
Recall number
Z-2725-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821751 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 165 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5, .070", REF SA6ECR35. for cardiovascular use

Z-2726-2019
Recall number
Z-2726-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824455 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 166 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. for cardiovascular use

Z-2727-2019
Recall number
Z-2727-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823229 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 167 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use

Z-2728-2019
Recall number
Z-2728-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822567 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 168 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use

Z-2729-2019
Recall number
Z-2729-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822017 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 169 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use

Z-2730-2019
Recall number
Z-2730-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824684 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 170 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for cardiovascular use

Z-2731-2019
Recall number
Z-2731-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824820 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 171 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use

Z-2732-2019
Recall number
Z-2732-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824738 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 172 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use

Z-2733-2019
Recall number
Z-2733-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821980 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 173 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use

Z-2734-2019
Recall number
Z-2734-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
330 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 20613994822196 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 174 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use

Z-2735-2019
Recall number
Z-2735-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821690 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 175 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use

Z-2736-2019
Recall number
Z-2736-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
52 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824363 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 176 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use

Z-2737-2019
Recall number
Z-2737-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823373 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 177 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use

Z-2738-2019
Recall number
Z-2738-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822604 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 178 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use

Z-2739-2019
Recall number
Z-2739-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994842176 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 179 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use

Z-2740-2019
Recall number
Z-2740-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824783 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 180 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for cardiovascular use

Z-2741-2019
Recall number
Z-2741-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823175 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 181 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use

Z-2742-2019
Recall number
Z-2742-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822871 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 182 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use

Z-2743-2019
Recall number
Z-2743-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823663 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 183 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use

Z-2744-2019
Recall number
Z-2744-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822635 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 184 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardiovascular use

Z-2745-2019
Recall number
Z-2745-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 20613994842248 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 185 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use

Z-2746-2019
Recall number
Z-2746-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822543 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 186 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use

Z-2747-2019
Recall number
Z-2747-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994824592 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 187 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use

Z-2748-2019
Recall number
Z-2748-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994822031 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 188 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use

Z-2749-2019
Recall number
Z-2749-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994823304 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 189 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use

Z-2750-2019
Recall number
Z-2750-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 20613994822233 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 190 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use

Z-2751-2019
Recall number
Z-2751-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821706 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

device · product 191 of 191

SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use

Z-2752-2019
Recall number
Z-2752-2019
Initiated
March 15, 2019
Classification
Class I
Status
Completed
Recalling firm
Medtronic Vascular
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Code information

GTIN: 00613994821812 All Lot/Serial Numbers

Distribution pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom