Device recall
Z-1017-05: Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-1017-05 |
|---|---|
| Recall event | 32465 |
| Product | Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343). |
| Product code | NIK |
| Recalling firm | St Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2012 |
| PMA numbers | P030054, P030054/S7, P910023, P910023/S77 |
| FEI number | 2017865 |
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