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
- Company
- Covidien Llc
- Recall Initiated
- November 23, 2020
- Recall Number
- Z-0747-2021
- Quantity
- 3255 units US; 3574 units OUS
- Firm Location
- Mansfield, MA
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 Taiwan Turkey United Arab Emirates United Kingdom Viet Nam
Lot / Code Info
Lot Numbers: P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY,P0D1454MYP0E1352MY,P0G0601Y, P0C0493MY UDI: 10884521043145, 20884521043142
Root Cause
Process control
Action Taken
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.