Device recall
Z-1228-2012: HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft…
FDA device recall · Class I · Thoratec Corporation
Key facts
| Recall number (Z-number) | Z-1228-2012 |
|---|---|
| Recall event | 61268 |
| Product | HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM… |
| Product code | DSQ |
| Recalling firm | Thoratec Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 8, 2012 |
| PMA numbers | P060040, P060040S004, P060040S005 |
| 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