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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75785

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

Open FDA event record

Event summary

Timeline bucket
October 05, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Oscor, Inc.

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

30 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 30

OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0790-2017
Recall number
Z-0790-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
156

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-09714 Exp. February 11, 2018, OR-04657 Exp. April 20, 2018, C1-10900 Exp. July 19, 2018, C1-10899 Exp. July 19, 2018, C1-11048 Exp. August 3, 2018, C1-11729 Exp. October 4, 2018, C1-11729 Exp. October 4, 2018, OR-04729 Exp. October 29, 2018, C1-12233 Exp. December 21, 2018, C1-12234 Exp. December 22, 2018, C1-12234 Exp. December 22, 2018, C1-09062 Exp. June 24, 2017, C1-09062 Exp. June 24, 2017, C1-11047 Exp. August 3, 2018 and C1-12234 Exp. December 22, 2018 2

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 2 of 30

OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0791-2017
Recall number
Z-0791-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
87

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-12312 Exp. January 18, 2019, OR-04686 Exp. July 16, 2018, Exp. April 21, 2015, OR-04655 Exp. April 20, 2018, C1-10985 Exp. July 28, 2018, OR-04686 Exp. July 16, 2018, C1-12312 Exp. January 18, 2019, C1-12312 Exp. January 18, 2019, and OR-04655 Exp. April 20, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 3 of 30

OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0792-2017
Recall number
Z-0792-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: OR-04634 Exp. March 10, 2018 and C1-12597 Exp. June 18, 2019

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 4 of 30

OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0793-2017
Recall number
Z-0793-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08337 Exp. November 7, 2016, OR-4658 Exp. April 20, 2018, C1-08337 Exp. November 7, 2016, and C1-08337 Exp. November 7, 2016

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 5 of 30

OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0794-2017
Recall number
Z-0794-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
991

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-12152 Exp. November 30, 2018, C1-09518 Exp. December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 6 of 30

OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0795-2017
Recall number
Z-0795-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
76

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-09374 Exp. November 5, 2017, C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11671 Exp. September 30, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11672 Exp. September 30, 2018, and C1-09374 Exp. November 5, 2017

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 7 of 30

OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0796-2017
Recall number
Z-0796-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
61

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, C1-11635 Exp. September 29, 2018, OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, and C1-09412 Exp. December 1, 2017

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 8 of 30

OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0797-2017
Recall number
Z-0797-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-09372 Exp. November 5, 2017, C1-10142 Exp. April 22, 2018 and OR-04728 Exp. October 21, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 9 of 30

OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0798-2017
Recall number
Z-0798-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: OR-04691 Exp. July 16, 2018, C1-11728 Exp. October 4, 2018, C1-09375 Exp. November 5, 2017 and C1-09375 Exp. November 5, 2017

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 10 of 30

OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0799-2017
Recall number
Z-0799-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, OR-04708 Exp. August 19, 2018, C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, C1-09373 Exp. November 5, 2017, C1-09373 Exp. November 5, 2017, OR-04708 Exp. August 19, 2018, and C1-11734 Exp. October 5, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 11 of 30

OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0800-2017
Recall number
Z-0800-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-09396 Exp. November 17, 2017, C1-09396 Exp. November 17, 2017, C1-08804 Exp. April 1, 2017, and C1-09396 Exp. November 17, 2017

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 12 of 30

OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0801-2017
Recall number
Z-0801-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
70

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-09395 Exp. November 17, 2017 and C1-11621 Exp. November 2, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 13 of 30

OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0802-2017
Recall number
Z-0802-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-12145 Exp. November 29, 2018, C1-08466 Exp. December 19, 2016 and OR-04823 Exp. June 16, 2019

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 14 of 30

OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0803-2017
Recall number
Z-0803-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
74

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-12572 Exp. June 17, 2019, C1-10896 Exp. July 16, 2018, C1-10896 Exp. July 16, 2018, C1-12139 Exp. November 24, 2018, C1-12572 Exp. June 17, 2019, C1-09133 Exp. August 3, 2017, C1-09133 Exp. August 3, 2017, C1-09943 Exp. March 19, 2018, OR-04641 Exp. March 26, 2018, and C1-10896 Exp. July 16, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 15 of 30

OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0804-2017
Recall number
Z-0804-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
124

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08611 Exp. February 20, 2017, C1-09397 Exp. November 17, 2017, C1-09408 Exp. November 25, 2017, C1-09408 Exp. November 25, 2017, C1-09861 Exp. March 5, 2018, C1-09858 Exp. March 5, 2018, C1-09861 Exp. March 5, 2018, C1-10901 Exp. July 19, 2018, C1-11205 Exp. August 24, 2018, C1-11205 Exp. August 24, 2018, C1-12250 Exp. January 4, 2019, C1-08611 Exp. February 20, 2017, and C1-11205 Exp. August 24, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 16 of 30

OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0805-2017
Recall number
Z-0805-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
110

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-09848 Exp. March 4, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, C1-09099 Exp. July 15, 2017, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017, C1-09848 Exp. March 4, 2018, C1-10382 Exp. May 17, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, OR-04730 Exp. October 29, 2018, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017 and C1-09848 Exp. March 4, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 17 of 30

OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0806-2017
Recall number
Z-0806-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
16

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: OR-04725 Exp. October 20, 2018, C1-10042 Exp. April 5, 2018, C1-10042 Exp. April 5, 2018, and C1-11868 Exp. October 20, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 18 of 30

OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0807-2017
Recall number
Z-0807-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
34

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-10984 Exp. July 28, 2018, C1-10983 Exp. July 28, 2018, C1-11198 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, C1-11198 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, and C1-10984 Exp. July 28, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 19 of 30

OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0808-2017
Recall number
Z-0808-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
33

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-11932 Exp. October 28, 2018, C1-08935 Exp. May 14, 2017, C1-11932 Exp. October 28, 2018, C1-12448 Exp. April 14, 2019, and C1-12448 Exp. April 14, 2019

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 20 of 30

OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0809-2017
Recall number
Z-0809-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-11201 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, and C1-11873 Exp. October 21, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 21 of 30

OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0810-2017
Recall number
Z-0810-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
255

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08260 Exp. October 6, 2016 and C1-08283 October 14, 2016

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 22 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0811-2017
Recall number
Z-0811-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
566

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08604 Exp. February 20, 2017, C1-08938Exp. May 19, 2017, C1-08986 Exp. June 1, 2017, OR-04488 Exp. June 30, 2017, C1-09756 Exp. February 18, 2018, C1-09757 Exp. February 18, 2018, OR-04633 Exp. March 10, 2018, C1-10118 Exp. April 17, 2018, C1-10119 Exp. April 17, 2018, C1-10147 Exp. April 23, 2018, and C1-12525 Exp. May 17, 2019

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 23 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0812-2017
Recall number
Z-0812-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
1,729

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 24 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0813-2017
Recall number
Z-0813-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
215

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08939 Exp. May 19, 2017, C1-08985 Exp. June 1, 2017, C1-09584 Exp. January 18, 2018, and C1-10120 Exp. April 17, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 25 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0814-2017
Recall number
Z-0814-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
186

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08466 Exp. December 19, 2016, C1-09857 Exp. March 5, 2018, C1-10215 Exp. April 29, 2018, and C1-11438 Exp. September 16, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 26 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0815-2017
Recall number
Z-0815-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
59

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08936 Exp. May 18, 2017 and OR-04635 Exp. March 10, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 27 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0816-2017
Recall number
Z-0816-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
1,269

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611 Exp. February 20, 2017, C1-08802 Exp. April 3, 2017, C1-08857 Exp. April 22, 2017, C1-09091 Exp. July 10, 2017, C1-09090 Exp. July 10, 2017, C1-09859 Exp. March 5, 2018, C1-09860 Exp. March 5, 2018, C1-09880 Exp. March 11, 2018, C1-09921 Exp. March 16, 2018, C1-10039 Exp. April 5, 2018, C1-10141 Exp. April 22, 2018, C1-10141 Exp. April 22, 2018, C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018, C1-10240 Exp. May 4, 2018, C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018, C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 16, 2018

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 28 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0817-2017
Recall number
Z-0817-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
991

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-08341 Exp. November 11, 2016, C1-08607 Exp. February 20, 2017, C1-08803 Exp. April 3, 2017, C1-08941 Exp. May 19, 2017, C1-09173 Exp. August 25, 2017, C1-09394 Exp. November 16, 2017, C1-09531 Exp. December 29, 2017, C1-09718 Exp. February 11, 2018, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018 53

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 29 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0818-2017
Recall number
Z-0818-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
55

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-12493 Exp. May 5, 2019

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

device · product 30 of 30

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Z-0819-2017
Recall number
Z-0819-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Oscor, Inc.
Quantity
45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information

Lot #'s: C1-12665 Exp. July 26, 2019

Distribution pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM