Recall Z-1538-2017— Heartware
Class I · Ongoing
Class I FDA medical device recall by Heartware, initiated 2017-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. Reason: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0).
- Recalling firm
- Heartware
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2017-02-03
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason for recall
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
Data sourced from openFDA. This site is unofficial and independent of the FDA.