Device recall
Z-0341-03: Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-0341-03 |
|---|---|
| Recall event | 25102 |
| Product | Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256 |
| Product code | DXY |
| Recalling firm | St Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2004 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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