Class II U.S. Food and Drug Administration

Boston Scientific Corporation Suture Cinch Long 1pk. Endoscopic tissue approximation recall: Device may fail to deploy the cinch implant and/or fail to cut the suture

Recall published 2 months ago

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2962-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Corporation
Product type
Medical devices
Units affected
60,654 units
Distribution
Nationwide
Made in
United States
Lot / code info
Material No. M00505550; GTIN: 00191506049188; Lot No. 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023412, 36054695, 36083619, 36116489, 36124315, 36138740, 36222818, 36222819, 36222960, 36231427, 36232903, 36238318, 36291083, 36298791, 36346089, 36346101, 36376494, 36390167, 36411916, 36428532, 36432020, 36443931, 36444025, 36453238, 36472920, 36472938, 36618380, 36624306, 36634952, 36646601, 36724691, 36846026, 36855626, 37019759, 37019868, 37031959, 37073352, 37086263, 37096406, 37108084, 37116726, 37124788, 37126750, 37128111, 37302211, 37399016, 37533710, 37586915, 37604205, 37663465, 38587149,38598199, 38823176, 38833088, 39053113, 39091844; Exp. Date Range: 26-Feb-2028 to 14-Apr-2029.
UPC codes
00191506049188

Products covered by this recall

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00191506049188

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 35903543
  • 35948104
  • 35948105
  • 35976434
  • 35976435
  • 35976436
  • 36023412

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 pk

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Boston Scientific Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Boston Scientific Corporation — 100 Boston Scientific Way, Marlborough, MA, 01752-1234

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Boston Scientific Corporation medical devices recalled?

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00191506049188; lot code 35903543, 35948104, 35948105. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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