FDA Alert: Implantable Left Ventricular Assist Devices (LVADs)

FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. FDA is also aware of bleeding complications related to both the Thoratec HeartMate II and HeartWare HVAD. [8/6/15]

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