Device recall
Z-1228-2014: HeartMate II System Controller Product Usage: HeartMate II is a mechanical…
FDA device recall · Class I · Thoratec Corporation
Key facts
| Recall number (Z-number) | Z-1228-2014 |
|---|---|
| Recall event | 67639 |
| Product | HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to… |
| Product code | DSQ |
| Recalling firm | Thoratec Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 27, 2015 |
| PMA numbers | P060040 |
| 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