Recall Z-1731-2015— HeartWare Inc
Class I · Ongoing
Class I FDA medical device recall by HeartWare Inc, initiated 2015-04-29. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP 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.. Reason: Complaints with the HVAD Internal Controller Alarm Battery failures..
- Recalling firm
- HeartWare Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2015-04-29
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP 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.
Reason for recall
Complaints with the HVAD Internal Controller Alarm Battery failures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.