Device recall
Z-1428-2020: HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is…
FDA device recall · Class I · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-1428-2020 |
|---|---|
| Recall event | 84829 |
| Product | HeartWare HVAD System Battery Charger AC Adapter 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), myocardial recovery, or as Destination Therapy (DT) in patients… |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 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