Medical Device Safety and Recalls: Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication

Today the FDA issued a safety communication regarding serious adverse events with Implantable Left Ventricular Assist Devices (LVADs). To date, there are two implantable LVADs approved by the FDA: The HeartMate II Left Ventricular Assist System manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System HVAD manufactured by HeartWare, Inc.

The FDA is aware of serious adverse events associated with both devices, and 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. We are also aware of bleeding complications associated with both devices.

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm457327.htm