Boston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
Boston Scientific is recalling Suture Cinch Long endoscopic tissue approximation devices because they may fail to deploy the implant or cut the suture.
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 functional failure of a medical device during a procedure. No injuries or illnesses are reported in the source text, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 60,654 units of Suture Cinch Long endoscopic tissue approximation devices. The recall covers devices with Material No. M00505550 and GTIN 00191506049188, distributed worldwide including the United States and numerous international markets.
The recall was initiated because the devices 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 should stop using the affected devices and contact Boston Scientific for instructions on return or replacement. The affected lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- Suture Cinch Long 1pk. Endoscopic tissue approximation device.
- Manufacturer
- Boston Scientific Corporation
- 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. M00505550
- GTIN: 00191506049188
- Lot No. 35903543
- 35948104
- 35948105
- 35976434
- 35976435
- 35976436
- 36023412
- 36054695
- 36083619
- 36116489
- 36124315
- 36138740
- 36222818
- 36222819
- 36222960
- 36231427
- 36232903
- 36238318
Distribution
Distributed nationwide across the United States.
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