Device recall
Z-0188-2018: Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-0188-2018 |
|---|---|
| Recall event | 78570 |
| Product | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel… |
| Product code | NIP |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2020 |
| PMA numbers | P110023, P110023S012 |
| FEI number | 2183870 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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