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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85227

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

Open FDA event record

Event summary

Timeline bucket
March 09, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific

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

12 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 12

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit

Z-1729-2020
Recall number
Z-1729-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
25,956

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24423656, 24423820, 24424087, 24427952, 24427959, 24428330, 24430010, 24437882, 24440182, 24440998, 24444952, 24446611, 24447516, 24447658, 24447722, 24447735, 24451828, 24452126, 24452132, 24452266, 24454238, 24455297, 24455381, 24455732, 24460452, 24460458, 24466032, 24487805, 24493956, 24494611, 24498583, 24498730, 24498732, 24499924, 24501439, 24506583, 24563429, 24563891, 24564727, 24564729, 24569684, 24570465, 24571203, 24579763, 24599358, 24609013, 24609991, 24614307, 24615296, 24620493, 24621357, 24621789, 24622541, 24623111, 24623117, 24623321, 24623461, 24623472, 24640257, 24661651, 24662199, 24663152, 24663562, 24663570, 24665001, 24665005, 24665100, 24665108, 24665990, 24666401, 24670677, 24672232, 24672553, 24678045, 24678047, 24681044, 24699798, 24700605, 24702016, 24708365, 24708371, 24709540, 24709550, 24710261, 24716280, 24716623, 24719303, 24723783, 24724284, 24732445, 24732731, 24738283, 24751717, 24756104, 24758578, 24763250, 24765356, 24766287, 24766401, 24772737, 24773528

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 2 of 12

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit

Z-1730-2020
Recall number
Z-1730-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
1,785

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 3 of 12

Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

Z-1731-2020
Recall number
Z-1731-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
5,565

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 4 of 12

Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

Z-1732-2020
Recall number
Z-1732-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
225

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24538844, 24647121

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 5 of 12

Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110

Z-1733-2020
Recall number
Z-1733-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
91 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24795838

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 6 of 12

Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

Z-1734-2020
Recall number
Z-1734-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
32

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Number: 24835477 (edited 1/13/2021)

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 7 of 12

Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

Z-1735-2020
Recall number
Z-1735-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Number: 24958079 (edited 1/13/2021)

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 8 of 12

Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080

Z-1736-2020
Recall number
Z-1736-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24879999, 25021676

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 9 of 12

Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080

Z-1737-2020
Recall number
Z-1737-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24755840

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 10 of 12

Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080

Z-1738-2020
Recall number
Z-1738-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24724232

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 11 of 12

Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080

Z-1739-2020
Recall number
Z-1739-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24755842

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

device · product 12 of 12

Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080

Z-1740-2020
Recall number
Z-1740-2020
Initiated
March 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Boston Scientific
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Code information

Lot Numbers: 24749818, 24913418

Distribution pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan