CanadaBoston Scientific is removing specific lots of OverStitch™ Suture Cinch (model/catalogue M00505540) and Suture Cinch–Long (model/catalogue M00505550), identified by the listed lot/serial numbers, used with OverStitch and X‑Tack endoscopic systems to secure and cut sutures. These devices may fail to deploy the cinch implant and/or fail to cut the suture, a fault not detectable on pre‑use inspection and apparent only when activated during a procedure. Contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: Suture Cinch - Long; Lot or serial number: 37663465; Model or catalogue number: M00505550
Affected products: Suture Cinch - Long; Lot or serial number: 37086263; Model or catalogue number: M00505550
Affected products: Suture Cinch - Long; Lot or serial number: 37604205; Model or catalogue number: M00505550
Affected products: Suture Cinch - Long; Lot or serial number: 37073352; Model or catalogue number: M00505550
Affected products: Suture Cinch - Long; Lot or serial number: 37586915; Model or catalogue number: M00505550
Affected products: Suture Cinch - Long; Lot or serial number: 37302211; Model or catalogue number: M00505550
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 38344889; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 38324701; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37292127; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37003596; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 38334198; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37940955; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37004909; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 38337305; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37307313; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 36938264; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37352684; Model or catalogue number: M00505540
Affected products: OverStitch™ Suture Cinch; Lot or serial number: 37688046; Model or catalogue number: M00505540
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States