Device recall
Z-2263-2020: Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J…
FDA device recall · Class I · Endologix, Inc.
Key facts
| Recall number (Z-number) | Z-2263-2020 |
|---|---|
| Recall event | 85480 |
| Product | Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J |
| Product code | MIH |
| Recalling firm | Endologix, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 3, 2024 |
| 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