Device recall
Z-0422-2010: HeartMate 12 volt sealed lead acid Battery Clips that are components of the…
FDA device recall · Class II · Thoratec Corp
Key facts
| Recall number (Z-number) | Z-0422-2010 |
|---|---|
| Recall event | 53561 |
| Product | HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2011 |
| PMA numbers | P060040, P920014 |
| FEI number | 2916596 |
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