Device recall
Z-2733-2011: SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE)…
FDA device recall · Class II · St Jude Medical CRMD
Key facts
| Recall number (Z-number) | Z-2733-2011 |
|---|---|
| Recall event | 58686 |
| Product | SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia |
| Product code | MXC |
| Recalling firm | St Jude Medical CRMD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2011 |
| 510(k) numbers | K081365 |
| FEI number | 2017865 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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