OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling approximately 60,654 units of its OverStitch Suture Cinch, an endoscopic tissue approximation device used in medical procedures. The device may fail to deploy the cinch implant and/or fail to cut the suture as intended. The affected product has Material No. M00505530 and was distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, the Middle East, and the Americas.
The recall affects specific lot numbers ranging from 36159783 through 37701280. The source document does not specify a remedy or what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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. M00505530; GTIN: 00191506060046; Lot No. 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, 36358240, 36366410, 36368880, 36370038, 36376493, 36390716, 36400755, 36413832, 36429438, 36440653, 36440659, 36440798, 36441070, 36441390, 36443933, 36450076, 36451398, 36452061, 36454608, 36454861, 36461432, 36466525, 36472307, 36472448, 36472813, 36473087, 36475081, 36482317, 36482413, 36482837, 36482838, 36486869, 36488822, 36496658, 36498004, 36500343, 36500745, 36508877, 36509436, 36511012, 36519283, 36519622, 36564120, 36567088, 36567089, 36651483, 36651990, 36660007, 36670672, 36689082, 36691535, 36691536, 36692473, 36715146, 36715947, 36722429, 36733894, 36736063, 36737026, 36742475, 36747253, 36754086, 36756476, 36767158, 36770136, 36795290, 36802913, 36816032, 36816864, 36819466, 36829515, 36837613, 36840422, 36855429, 36859432, 36870323, 36884519, 36886399, 36887192, 36894183, 36906859, 37049911, 37053262, 37063221, 37071091, 37082225, 37256930, 37258435, 37265997, 37268058, 37276648, 37277853, 37332709, 37335148, 37341879, 37431423, 37462817, 37475144, 37479080, 37512600, 37516705, 37538409, 37614916, 37628854, 3770128
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.