Drug recall
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103…
FDA recall event 67466 · Class I · HeartWare Inc
Key facts
| Event ID | 67466 |
|---|---|
| Recall numbers | Z-1471-2014 |
| Recalling firm | HeartWare Inc |
| Product type | Devices |
| Products | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. |
| Initiation date | Dec 6, 2013 |
| Report date | Apr 30, 2014 |
| Termination date | Nov 3, 2016 |
| 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: