OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Summary
The FDA issued a Class II for OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. by Boston Scientific Corporation. Reason: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended..
Details
Source
Device Recall
External ID
Z-2961-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
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.
Quantity Affected: 60,654 units
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, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-14
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Boston Scientific Corporation has 424 FDA actions in our database, including 355 recalls and 69 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 424 FDA actions in our database, including 355 recalls and 69 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2961-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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