Boston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
Boston Scientific is recalling OverStitch Suture Cinch devices because they may fail to deploy the implant or cut the suture as intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a device failure that could lead to harm during a medical procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling the OverStitch Suture Cinch, an endoscopic tissue approximation device. The recall involves 60,654 units distributed worldwide, including the United States and numerous international markets.
The recall is being conducted because the device may fail to deploy the cinch implant and/or fail to cut the suture as intended. This malfunction could prevent the device from performing its intended function during endoscopic procedures.
Healthcare providers and facilities that have received these devices should stop using them and contact Boston Scientific for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 60,654
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Material No. M00505530
- GTIN: 00191506060046
- Lot No. 36159783
- 36179248
- 36179249
- 36179250
- 36179674
- 36181153
- 36193585
- 36195262
- 36195281
- 36213130
- 36213131
- 36222433
- 36223110
- 36233350
- 36233423
- 36233424
- 36238771
- 36246477
Distribution
Distributed nationwide across the United States.
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