Device recall
Z-0291-2024: Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-0291-2024 |
|---|---|
| Recall event | 93195 |
| Product | Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal… |
| Product code | PRL |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P120003 |
| FEI number | 3011175548 |
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