Medical Device Safety and Recalls: HeartWare Ventricular Assist System (VAS) – Electrostatic Discharge May Cause Pump Failure

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: HeartWare Ventricular Assist System (VAS) – Electrostatic Discharge May Cause Pump Failure

A recall has been issued for the HeartWare Ventricular Assist System (VAS).  A buildup of static may cause a sudden discharge of electricity (electrostatic discharge) in the device. When this happens, data in the motor controller that manages the pump’s operation may be corrupted and the device may stop working. This problem occurs more often in older model controllers distributed during the clinical trials.

If the pump stops working, it can lead to serious adverse health consequences, including death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm435811.htm

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