Device recall
Z-0288-2013: TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment…
FDA device recall · Class II · Trivascular, Inc
Key facts
| Recall number (Z-number) | Z-0288-2013 |
|---|---|
| Recall event | 63586 |
| Product | TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta… |
| Product code | MIH |
| Recalling firm | Trivascular, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2012 |
| 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