Device recall
Z-0067-2019: Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403…
FDA device recall · Class II · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-0067-2019 |
|---|---|
| Recall event | 80966 |
| Product | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT)… |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2019 |
| PMA numbers | P100047 |
| FEI number | 3007042319 |
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