Recall Z-2136-2021 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Medtronic Vascular, Inc.
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
| Date | Jun 7, 2021 |
| Status | Open, Classified |
| Reason | During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover. |
| Root cause | Under Investigation by firm |
| Action | On 06/07/2021, the firm initiated a verbal notification regarding an "URGENT MEDICAL DEVICE RECALL" which informed customers that Earlier this week, Medtronic identified the potential for a specific subset of 20Fr Endurant II/IIs Stent Graft Systems to have the potential for the Radiopaque Marker to detach during deployment. There is evidence that devices that used one batch of graft cover subassemblies has a higher potential to exhibit this failure mode. This is an acute failure of the delivery system, there are no concerns with previously implanted stent grafts. We are requesting that you im |
| Quantity | 21 devices |
| Distribution | U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.