Device recall
Z-1832-2017: HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product…
FDA device recall · Class I · Heartware
Key facts
| Recall number (Z-number) | Z-1832-2017 |
|---|---|
| Recall event | 76807 |
| Product | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side). |
| Product code | DSQ |
| Recalling firm | Heartware |
| 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