Device recall
Z-1108-2023: The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-1108-2023 |
|---|---|
| Recall event | 91359 |
| Product | The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated. |
| Product code | PFV |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2020394 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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