Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
Check against the official notice below — it lists the full affected range.
Covidien is recalling the TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3 because certain units may contain a damaged internal component that could prevent proper staple deployment and formation. If the staple line does not function correctly, it may fail to stop bleeding or could lead to serious complications including anastomotic leak, pneumothorax, tissue damage, infection, peritonitis, and sepsis. The recalled devices were distributed nationwide and internationally across numerous countries. A total of 3,255 units were distributed in the United States and 3,574 units were distributed outside the United States across the affected lot numbers.
The recall affects specific lot numbers including P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY, P0D1454MY, P0E1352MY, P0G0601Y, and P0C0493MY, which can be identified using the UDI numbers 10884521043145 and 20884521043142. The source does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
Reason for recall: May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis Distribution: Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martinique Morocco Myanmar, Netherlands Norway Pakistan Poland Russian Federation Serbia Singapore Slovakia Spain Sweden Switzerland Taiw Quantity: 3255 units US; 3574 units OUS Lot/code info: Lot Numbers: P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY,P0D1454MYP0E1352MY,P0G0601Y, P0C0493MY UDI: 10884521043145, 20884521043142
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.