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.
What this means for you
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.
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12