Boston Scientific recalls OverStitch Suture Cinch devices that may fail to deploy the cinch implant or cut suture as intended. Affected units have specific lot numbers and expiration dates.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific is recalling OverStitch Suture Cinch devices that might not work properly during surgery. This could lead to improper tissue approximation if the device fails to deploy or cut the suture as intended.
The device may fail to deploy the cinch implant or cut the suture as intended during surgery. This could result in improper tissue approximation, potentially affecting surgical outcomes.
Medical professionals using the OverStitch Suture Cinch device during surgical procedures are most at risk. Patients undergoing surgery with this device may be affected if the recall applies to their procedure.
Check the product label for the lot numbers listed in the recall (e.g., 36159783, 36179248, etc.) and expiration dates between March 25, 2028 and April 19, 2029.
Look for the lot numbers listed in the recall (e.g., 36159783, 36179248, etc.) and expiration dates between March 25, 2028 and April 19, 2029.
The OverStitch Suture Cinch is an endoscopic tissue approximation device used in surgical procedures.
Check the product label for lot numbers listed in the recall (e.g., 36159783, 36179248, etc.) and expiration dates between March 25, 2028 and April 19, 2029.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2961-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2961-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
