Recall Z-1131-2015— HeartWare Inc
Class I · Terminated
Class I FDA medical device recall by HeartWare Inc, initiated 2015-01-16, terminated 2020-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: 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 System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.. Reason: The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers..
- Recalling firm
- HeartWare Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-01-16
- Terminated
- 2020-02-05
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: 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 System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.