Device recall
Z-0506-2026: Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone)…
FDA device recall · Class II · Thoratec LLC
Key facts
| Recall number (Z-number) | Z-0506-2026 |
|---|---|
| Recall event | 97782 |
| Product | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller… |
| Product code | DSQ |
| Recalling firm | Thoratec LLC |
| Recall class | Class II |
| 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