Recall Monitor
Health Products

OverStitch™ Suture Cinch and Suture Cinch–Long

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: OverStitch™ Suture Cinch and Suture Cinch–Long
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Suture Cinch - Long37663465M00505550
Suture Cinch - Long37086263M00505550
Suture Cinch - Long37604205M00505550
Suture Cinch - Long37073352M00505550
Suture Cinch - Long37586915M00505550
Suture Cinch - Long37302211M00505550
OverStitch™ Suture Cinch38344889M00505540
OverStitch™ Suture Cinch38324701M00505540
OverStitch™ Suture Cinch37292127M00505540
OverStitch™ Suture Cinch37003596M00505540
OverStitch™ Suture Cinch38334198M00505540
OverStitch™ Suture Cinch37940955M00505540
OverStitch™ Suture Cinch37004909M00505540
OverStitch™ Suture Cinch38337305M00505540
OverStitch™ Suture Cinch37307313M00505540
OverStitch™ Suture Cinch36938264M00505540
OverStitch™ Suture Cinch37352684M00505540
OverStitch™ Suture Cinch37688046M00505540

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.

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