Device recall
Z-2052-2017: HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL…
FDA device recall · Class I · Thoratec Corporation
Key facts
| Recall number (Z-number) | Z-2052-2017 |
|---|---|
| Recall event | 76978 |
| Product | HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital. |
| Product code | DSQ |
| Recalling firm | Thoratec Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 20, 2019 |
| 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