Device recall
Z-0058-2011: HeartMate II System Controller, a component of the HeartMate II Left Ventricular…
FDA device recall · Class II · Thoratec Corp
Key facts
| Recall number (Z-number) | Z-0058-2011 |
|---|---|
| Recall event | 56694 |
| Product | HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2011 |
| 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