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Boston Scientific Corporation recalls OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Recalled August 26, 2026 · FDA recall Z-2961-2026 · Boston Scientific
Hazard
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. · FDA Class II
Units
60,654 units
Sold at
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.
Description
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Product
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →