← Back to all recalls
MEDICAL DEVICE RECALLMODERATE
OverStitch Suture Cinch
Boston Scientific recalls OverStitch Suture Cinch over deployment and suture-cutting failures.
What to do
Contact Boston Scientific for instructions on returning the affected device and for information on replacement or correction.
Recall at a glance
- Quantity recalled
- 60,654 units
Why it was recalled
Boston Scientific is recalling the OverStitch Suture Cinch, an endoscopic tissue approximation device, because the device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. | 36159783, 36179248, 36179249, 36179250, 36179674, 36181153, 36193585, 36195262, 36195281, 36213130, 36213131, 36222433, 36223110, 36233350, 36233423, 36233424, 36238771, 36246477, 36247744, 36247745, 36257144, 36257145, 36264795, 36266604, 36285303, 36285304, 36291094, 36291142, 36296642, 36297718, 36298785, 36299374, 36307286, 36335098, 36336245, 36336246, 36336247, 36336248, 36336249, 36349543 (+182 more, see the official notice) | Z-2961-2026 | 00191506060046, 36159783, 36179248, 36179249, 36179250, 36179674, 36181153, 36193585, 36195262, 36195281, 36213130, 36213131, 36222433, 36223110, 36233350, 36233423, 36233424, 36238771, 36246477, 36247744 |
| Suture Cinch Long 1pk. Endoscopic tissue approximation device. | 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023412, 36054695, 36083619, 36116489, 36124315, 36138740, 36222818, 36222819, 36222960, 36231427, 36232903, 36238318, 36291083, 36298791, 36346089, 36346101, 36376494, 36390167, 36411916, 36428532, 36432020, 36443931, 36444025, 36453238, 36472920, 36472938, 36618380, 36624306, 36634952, 36646601, 36724691, 36846026, 36855626, 37019759 (+22 more, see the official notice) | Z-2962-2026 | 00191506049188, 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023412, 36054695, 36083619, 36116489, 36124315, 36138740, 36222818, 36222819, 36222960, 36231427, 36232903, 36238318, 36291083 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification