Recall Z-2961-2026— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-07-14. It names 2 FDA 510(k) clearances: K201808, K181141. Product: OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.. Reason: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-14
- Firm location
- Marlborough, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K201808 — X-Tack Endoscopic HeliX Tacking System
- K181141 — OverStitch Endoscopic Suturing System and Accessories
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Reason for recall
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.