Recall Z-1917-2015— HeartWare Inc

Name: FDA recall Z-1917-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-29

Class II · Ongoing

Class II 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) 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: Complaints with the HVAD Abnormal Power Source Switching..

Recalling firm: HeartWare Inc
Classification: Class II
Status: Ongoing
Initiated: 2015-04-29
Firm location: Miami Lakes, FL, United States

Product description

HeartWare Ventricular Assist System (HVAD) 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

Complaints with the HVAD Abnormal Power Source Switching.

Data sourced from openFDA. This site is unofficial and independent of the FDA.