Device recall
Z-0429-2012: Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical…
FDA device recall · Class II · St Jude Medical CRMD
Key facts
| Recall number (Z-number) | Z-0429-2012 |
|---|---|
| Recall event | 60134 |
| Product | Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. |
| Product code | DXY |
| Recalling firm | St Jude Medical CRMD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2012 |
| PMA numbers | P030035, P880086 |
| 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