Device recall
Z-1301-2024: HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow…
FDA device recall · Class I · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-1301-2024 |
|---|---|
| Recall event | 93963 |
| Product | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P160054 |
| 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