Class 2 Device Recall Covidien TA Auto Suture Vascular Stapler

• Date Initiated by Firm: November 23, 2020
• Create Date: December 29, 2020
• Recall Status: Completed
• Recall Number: Z-0747-2021
• Recall Event ID: 86886
• 510(K)Number: K111825
• Product Classification: Staple, implantable - Product Code GDW
• Product: 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
• Code Information: Lot Numbers: P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY,P0D1454MYP0E1352MY,P0G0601Y, P0C0493MY UDI: 10884521043145, 20884521043142
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: 508-261-8000
• Manufacturer 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
• FDA Determined Cause: Process control
• Action: Medtronic issued Urgent Medical Device Recall letter by letter delivered via Federal Express and/or certified mail beginning November 23, 2020. The letter states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed above. 2. Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3. If you have distributed the Covidien TA" Auto Suture" Vascular Stapler and Loading Unit with DST Series" Technology listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory We request that you contact Medtronic if you experienced a quality problem or adverse event. Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
• Quantity in Commerce: 3255 units US; 3574 units OUS
• 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 Taiwan Turkey United Arab Emirates United Kingdom Viet Nam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = GDW