DUBLIN., The United States Food and Drug Administration (FDA) has classified Medtronic plc's recent voluntary urgent field action related to the HeartWare(TM) HVAD(TM) System unexpected power source ...
The US Food and Drug Administration (FDA) has classified a recent field action undertaken by Medtronic for their HeartWare HVAD system as a Class I recall. Last month, Medtronic issued an alert to ...