Drug recall
HeartWare Ventricular Assist Device (HVAD) System
FDA recall event 89559 · Class II · Heartware, Inc.
Key facts
| Event ID | 89559 |
|---|---|
| Recall numbers | Z-0726-2022 |
| Recalling firm | Heartware, Inc. |
| Product type | Devices |
| Products | HeartWare Ventricular Assist Device (HVAD) System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the… |
| Initiation date | Jan 27, 2022 |
| Report date | Mar 16, 2022 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 3007042319 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: