Recall Z-1607-2014— HeartWare Inc
Class II · Terminated
Class II FDA medical device recall by HeartWare Inc, initiated 2014-04-16, terminated 2016-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage 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: Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced..
- Recalling firm
- HeartWare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-16
- Terminated
- 2016-10-03
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage 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
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
Data sourced from openFDA. This site is unofficial and independent of the FDA.