Public recall detail

OverStitch™ Suture Cinch and Suture Cinch–Long

2026-07-23

medium
Health products Health product recall
Quick summary

Quick summary: OverStitch™ Suture Cinch and Suture Cinch–Long. Reason: Health product recall. Category: Health products. Date: 2026-07-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: OverStitch™ Suture Cinch and Suture Cinch–Long. Reason: Health product recall. Category: Health products. Date: 2026-07-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBOSTON SCIENTIFIC CORPORATION
ProductOverStitch™ Suture Cinch and Suture Cinch–Long
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82395

Affected products

ProductSuture Cinch - Long
Lot37663465
ModelM00505550
Serial number37663465
DescriptionSuture Cinch - Long
ProductSuture Cinch - Long
Lot37086263
ModelM00505550
Serial number37086263
DescriptionSuture Cinch - Long
ProductSuture Cinch - Long
Lot37604205
ModelM00505550
Serial number37604205
DescriptionSuture Cinch - Long
ProductSuture Cinch - Long
Lot37073352
ModelM00505550
Serial number37073352
DescriptionSuture Cinch - Long
ProductSuture Cinch - Long
Lot37586915
ModelM00505550
Serial number37586915
DescriptionSuture Cinch - Long
ProductSuture Cinch - Long
Lot37302211
ModelM00505550
Serial number37302211
DescriptionSuture Cinch - Long
ProductOverStitch™ Suture Cinch
Lot38344889
ModelM00505540
Serial number38344889
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot38324701
ModelM00505540
Serial number38324701
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37292127
ModelM00505540
Serial number37292127
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37003596
ModelM00505540
Serial number37003596
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot38334198
ModelM00505540
Serial number38334198
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37940955
ModelM00505540
Serial number37940955
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37004909
ModelM00505540
Serial number37004909
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot38337305
ModelM00505540
Serial number38337305
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37307313
ModelM00505540
Serial number37307313
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot36938264
ModelM00505540
Serial number36938264
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37352684
ModelM00505540
Serial number37352684
DescriptionOverStitch™ Suture Cinch
ProductOverStitch™ Suture Cinch
Lot37688046
ModelM00505540
Serial number37688046
DescriptionOverStitch™ Suture Cinch

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesBoston Scientific Corporation300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Recall date2026-07-14
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82395
Background{}
CompaniesBoston Scientific Corporation300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
AudiencesHealthcare
Source updated2026-07-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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