Device recall
Z-1993-2023: HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b)…
FDA device recall · Class II · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-1993-2023 |
|---|---|
| Recall event | 92350 |
| Product | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class II |
| 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