Device recall
Z-1227-2014: HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with…
FDA device recall · Class I · Thoratec Corporation
Key facts
| Recall number (Z-number) | Z-1227-2014 |
|---|---|
| Recall event | 67639 |
| Product | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) 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. |
| 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