Boston Scientific Corporation recalls Suture Cinch Long 1pk. Endoscopic tissue approximation device.

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

An Urgent Medical Device Removal notification dated 7/14/26 was mailed to consignees instructing them to immediately stop further use or distribution of affected devices. Consignees are to forward the notice to relevant personnel and to facilities where product was further distributed. Healthcare personnel are to monitor patients that received care with affected devices per the standard of care. The provided response form is to be completed and returned to Boston Scientific, and product returned in accordance with the provided instructions. Consignees with any quality concerns can email BSCComplaints@bsci.com.

• FDA enforcement recordOfficial FDA database entry for Z-2962-2026
• FDA 510(k) clearance · K181141The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201808The device's official FDA premarket clearance record
• FDA device classification · OCWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.