Device recall
Z-1582-2009: Cardiomedics CardiAssist External Counterpulsation System, circulatory assist…
FDA device recall · Class II · Cardiomedics Incorporated
Key facts
| Recall number (Z-number) | Z-1582-2009 |
|---|---|
| Recall event | 52223 |
| Product | Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000. |
| Product code | DRN |
| Recalling firm | Cardiomedics Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2012 |
| 510(k) numbers | K050172 |
| FEI number | 2025845 |
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