Device recall
Z-0709-05: Implantable Cardioverter-Defibrillator Models affected include the following…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-0709-05 |
|---|---|
| Recall event | 31515 |
| Product | Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343 |
| Product code | NIK |
| Recalling firm | St Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2005 |
| PMA numbers | P030054, P910023 |
| 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