Recall Z-1698-2015— 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. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.. Reason: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller..
- 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. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Reason for recall
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Data sourced from openFDA. This site is unofficial and independent of the FDA.