Recall Z-2961-2026 ยท OCW Endoscopic Tissue Approximation Device
Boston Scientific Corporation
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
| Date | Aug 14, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. |
| Root cause | Under Investigation by 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 BSCCom |
| Quantity | 60,654 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |