Device recall
Z-0125-2015: Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The…
FDA device recall · Class I · Trivascular, Inc
Key facts
| Recall number (Z-number) | Z-0125-2015 |
|---|---|
| Recall event | 69326 |
| Product | Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs). |
| Product code | MIH |
| Recalling firm | Trivascular, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 4, 2014 |
| PMA numbers | P120006 |
| FEI number | 3008011247 |
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