OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
FDA device recall Z-2961-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- Action taken
- 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 BSCComplaints@bsci.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OCW
- Quantity affected
- 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, Fra
- Date initiated
- 2026-07-14
- Date posted
- 2026-08-14
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| X-Tack Endoscopic HeliX Tacking System (K201808) | Apollo Endosurgery, Inc. | 2020-12-15 |
| OverStitch Endoscopic Suturing System and Accessories (K181141) | Apollo Endosurgery | 2018-06-27 |