Device recall
Z-2291-2025: Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number…
FDA device recall · Class I · Thoratec LLC
Key facts
| Recall number (Z-number) | Z-2291-2025 |
|---|---|
| Recall event | 97256 |
| Product | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to… |
| Product code | DSQ |
| Recalling firm | Thoratec LLC |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P060040, 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