Boston Scientific Corporation: Endoscopic Tissue Approximation Device
- Recalling firm
- Boston Scientific Corporation
- Product
- OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Reason
- Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-14
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c82e9114-f082-4188-9d53-77a95b3db4cf