Device recall
Z-1300-2024: HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed…
FDA device recall · Class I · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-1300-2024 |
|---|---|
| Recall event | 93963 |
| Product | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class I |
| Status | Open, Classified |
| 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