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

Medical DevicesSource: FDA (device) · Date: 2026-08-26

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Boston Scientific Corporation
Product
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Reason / hazard
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Classification
Class II
Status
Ongoing
Distribution / sold at
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, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.
Recall initiated
2026-07-14
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.
Product quantity
60,654 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
99435
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