OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
FDA Recall Z-2961-2026 · Posted 2026-08-14
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Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeOCW
Date Initiated2026-07-14
Product Quantity60,654 units
Reason for Recall
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Firm Action
An Urgent Medical Device Removal notification dated 7/14/26 was mailed to consignees instructing them to immediately stop further use or distribution of affected devices. Consignees are to forward the notice to relevant personnel and to facilities where product was further distributed. Healthcare personnel are to monitor patients that received care with affected devices per the standard of care. The provided response form is to be completed and returned to Boston Scientific, and product returned in accordance with the provided instructions. Consignees with any quality concerns can email [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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