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

Is my product affected?

Suture Cinch Long 1pk. Endoscopic tissue approximation device.

• UPC 00191506049188

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling the Suture Cinch Long 1pk, an endoscopic tissue approximation device, because the device may fail to deploy the cinch implant and/or fail to cut the suture as intended. The recall affects approximately 60,654 units distributed worldwide, including across the United States and numerous countries in Europe, Asia, the Middle East, and the Americas. The affected devices have specific lot numbers ranging from 35903543 to 39091844, with expiration dates between February 26, 2028, and April 14, 2029.

The recall record does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slova Quantity: 60,654 units Lot/code info: 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, 36291083, 36298791, 36346089, 36346101, 36376494, 36390167, 36411916, 36428532, 36432020, 36443931, 36444025, 36453238, 36472920, 36472938, 36618380, 36624306, 36634952, 36646601, 36724691, 36846026, 36855626, 37019759, 37019868, 37031959, 37073352, 37086263, 37096406, 37108084, 37116726, 37124788, 37126750, 37128111, 37302211, 37399016, 37533710, 37586915, 37604205, 37663465, 38587149,38598199, 38823176, 38833088, 39053113, 39091844; Exp. Date Range: 26-Feb-2028 to 14-Apr-2029.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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