FDA-Device2026-08-26Class IIPROCESSING DEFECT
Boston Scientific OverStitch Suture Cinch recalled for deployment and cutting failure risk
What this means
The Boston Scientific OverStitch Suture Cinch, an endoscopic device used to approximate and close tissue during procedures, may fail to deploy the cinch implant or fail to cut the suture as intended. This malfunction could compromise the effectiveness of the procedure. The recall affects specific lot numbers distributed worldwide.
- Check if your facility has affected lot numbers (36159783–39114250, expiration March 2028 to April 2029)
- Contact Boston Scientific or your supplier for instructions on affected units
- Do not use devices from recalled lots for new procedures
- Follow your facility's protocol for quarantining and handling recalled medical devices
The agency's original wording
Hazard
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
60,654 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2961-2026More Boston Scientific recalls
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