Device recall
Z-2348-2019: Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only…
FDA device recall · Class II · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-2348-2019 |
|---|---|
| Recall event | 83357 |
| Product | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2020 |
| 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