Recall of specific lots of Covidien TA™ Auto Suture™ Vascular Stapler and Loading Unit with DST Series™ Technology with potential for impeded staple deployment

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of a voluntary recall of specific lots of Covidien TA^™ Auto Suture^™ Vascular Stapler and Loading Unit with DST Series^™ Technology (models TA30V3S and TA30V3L respectively), due to a damaged internal component which could impede staple deployment. The use of an affected device may 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. Manufacturing process improvements have been implemented to remediate this issue. There have been no confirmed complaints received related to this issue. As effects on the staple line should be immediately evident to the surgeon in the form of incomplete staple formation or a non-functional staple line, no further action is required if the operation has completed with no staple-line related complications. Healthcare professionals are advised to return all unused affected items and monitor existing patients implanted with affected devices in accordance to current institution protocols and standard of care. Please refer to the letter for details. Published: 9 Dec 2020

Dear Healthcare Professional Letters