Hazard description
Boston Scientific is initiating removal of specific lots of OverStitch™ Suture Cinch and Suture Cinch-Long (collectively "Suture Cinch"). these devices are accessories used with the OverStitch™ Endoscopic Suturing System, OverStitch™ NXT Endoscopic Suturing System, and the X-Tack™ Endoscopic HeliX Tacking System to secure and cut the proximal end of a suture through the working channel of a gastroscope or colonoscope.During device activation, the Suture Cinch may fail to deploy the cinch implant and/or fail to cut the suture as intended. The issue cannot be detected through pre-use inspection but becomes apparent once the user attempts to deploy the device during the procedure.
RecallTracker