Recall Z-0747-2021 ยท GDW Staple, Implantable
Covidien Llc
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
| Date | Nov 23, 2020 |
| Status | Completed |
| Reason | 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 |
| Root 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 li |
| Quantity | 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, Netherl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS Covidien, Formerly US Surgical A Divison of Tyco H, Oct 25, 2011 |