Recall Z-1471-2014— HeartWare Inc
Class I · Terminated
Class I FDA medical device recall by HeartWare Inc, initiated 2013-12-06, terminated 2016-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.. Reason: The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector..
- Recalling firm
- HeartWare Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-12-06
- Terminated
- 2016-11-03
- Firm location
- Miami Lakes, FL, United States
Product description
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 risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.