Recall Z-2504-2018 ยท GDW Staple, Implantable
COVIDIEN MEDTRONIC
Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
| Date | Jul 19, 2018 (initiated May 22, 2018) |
| Status | Open, Classified |
| Reason | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. |
| Root cause | Process control |
| Action | On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018. Customers are advised to take the following required actions: 1. Immediately discontinue use, and quarantine affected products listed 2. Return affected product as indicated. 3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below: * Product purchased directly from Medtronic: feedback.customerservice@Covidien.com or fax to (80 |
| Distribution | Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mal |
| 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 |