Device recall
Z-1325-2008: Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy…
FDA device recall · Class II · St Jude Medical CRMD
Key facts
| Recall number (Z-number) | Z-1325-2008 |
|---|---|
| Recall event | 46870 |
| Product | Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy cardioverter/defibrillator, Model V-196 |
| Recalling firm | St Jude Medical CRMD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2012 |
| PMA numbers | P030054, P910023 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
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