Device recall
Z-0496-2009: Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog…
FDA device recall · Class II · Thoratec Corp
Key facts
| Recall number (Z-number) | Z-0496-2009 |
|---|---|
| Recall event | 50091 |
| Product | Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. Product is manufactured and distributed by Thoratec Corporation, Pleasant, CA. The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 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