FDA-Device2026-08-26Class IIPROCESSING DEFECT
Boston Scientific Suture Cinch Long recalled for potential deployment failure
What this means
Boston Scientific has recalled certain Suture Cinch Long endoscopic tissue approximation devices due to a malfunction risk. The device may fail to deploy the cinch implant properly and/or fail to cut the suture as intended during the procedure.
- Check if you have an affected device by lot number (35903543 through 39053113, expiring Feb 2028–Apr 2029).
- Contact Boston Scientific or your healthcare provider immediately if you have one of these devices.
- Do not use an affected device until you have consulted with your healthcare provider.
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
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2962-2026More Boston Scientific recalls
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