Device recall
Z-2135-2021: Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-2135-2021 |
|---|---|
| Recall event | 88158 |
| Product | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach. |
| Product code | MIH |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P100021 |
| FEI number | 3005364322 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database