Device recall
Z-1297-2014: Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910…
FDA device recall · Class II · Trivascular, Inc
Key facts
| Recall number (Z-number) | Z-1297-2014 |
|---|---|
| Recall event | 67672 |
| Product | Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent… |
| Product code | MIH |
| Recalling firm | Trivascular, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2014 |
| PMA numbers | P120006, P120006S008 |
| 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