Device recall
Z-0746-2020: HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and…
FDA device recall · Class II · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-0746-2020 |
|---|---|
| Recall event | 84379 |
| Product | HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2022 |
| 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