Boston Scientific Corporation recalls OverStitch Suture Cinch, 1pk. Endoscopic tissue approximatio

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

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, 37701281, 37712590, 37747392, 37759135, 37768422, 37780435, 37804241, 37813732, 37824328, 37846636, 37861753, 37874884, 37906665, 37952534, 37976914, 37980916, 37987576, 38001581, 38020339, 38045267, 38055953, 38064514, 38087625, 38092029, 38119620, 38134479, 38149599, 38168976, 38265895, 38274202, 38277823, 38298897, 38307807, 38355532, 38404637, 38421970, 38438020, 38441891, 38448572, 38458999, 38480821, 38495024, 38498977, 38505659, 38526386, 38527090, 38540408, 38613546, 38620724, 38629370, 38672064, 38682255, 38692722, 38709195, 38711985, 38728857, 38738005, 38748320, 38759951, 38771565, 38787506, 38798542, 38808911, 38847193, 38866237, 38886764, 38917596, 38926776, 38936218, 38939941, 38948809, 39018825, 39029561, 39032429, 39043147, 39095582, 39114250, 39131778; Exp. Dat Range 25-Mar-2028 to 19-Apr-2029.