Drug recall
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac…
FDA recall event 70340 · Class I · HeartWare Inc
Key facts
| Event ID | 70340 |
|---|---|
| Recall numbers | Z-1131-2015 |
| Recalling firm | HeartWare Inc |
| Product type | Devices |
| Products | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers. |
| Initiation date | Jan 16, 2015 |
| Report date | Mar 4, 2015 |
| Termination date | Feb 5, 2020 |
| 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: