Device recall
Z-1774-2018: Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524…
FDA device recall · Class I · Abbott
Key facts
| Recall number (Z-number) | Z-1774-2018 |
|---|---|
| Recall event | 79893 |
| Product | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure. |
| Product code | DSQ |
| Recalling firm | Abbott |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 15, 2021 |
| 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