OverStitch™ Suture Cinch and Suture Cinch–Long
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Suture Cinch - Long |
37663465 |
M00505550 |
Suture Cinch - Long |
37086263 |
M00505550 |
Suture Cinch - Long |
37604205 |
M00505550 |
Suture Cinch - Long |
37073352 |
M00505550 |
Suture Cinch - Long |
37586915 |
M00505550 |
Suture Cinch - Long |
37302211 |
M00505550 |
OverStitch™ Suture Cinch |
38344889 |
M00505540 |
OverStitch™ Suture Cinch |
38324701 |
M00505540 |
OverStitch™ Suture Cinch |
37292127 |
M00505540 |
OverStitch™ Suture Cinch |
37003596 |
M00505540 |
OverStitch™ Suture Cinch |
38334198 |
M00505540 |
OverStitch™ Suture Cinch |
37940955 |
M00505540 |
OverStitch™ Suture Cinch |
37004909 |
M00505540 |
OverStitch™ Suture Cinch |
38337305 |
M00505540 |
OverStitch™ Suture Cinch |
37307313 |
M00505540 |
OverStitch™ Suture Cinch |
36938264 |
M00505540 |
OverStitch™ Suture Cinch |
37352684 |
M00505540 |
OverStitch™ Suture Cinch |
37688046 |
M00505540 |
Issue
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.
Additional information
Details
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Get notified
Receive emails about new and updated recall and safety alerts.