Posts Tagged 'heartware'

Medtronic Heart Pump Recalled Over Potentially Fatal Flaw

medtronic heartware hvad system under recallLast year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.

Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic was aware of ...

continue reading...

FDA Warns of Adverse Events with Heart Devices

fda issues warning on heart devicesThe U.S. Food and Drug Administration (FDA) has issued a safety communication warning of serious adverse events associated with two implantable left ventricular assist devices. The two heart systems, which happen to be the only implantable devices of their kind approved by the FDA, are the HeartMate II Left Ventricular Assist System, manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System, manufactured by HeartWare, Inc.

According to the FDA ...

continue reading...