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MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Today, the U.S. Food and Drug Administration (FDA) is updating its Medtronic HeartWare Ventricular Assist Device System website to include information on the availability of a backup controller with modified software that may help to restart the pump if the primary controller fails to restart the pump.
Questions?
If you have questions about the Medtronic HeartWare Ventricular Assist Device (HVAD) System, contact the Division of Industry and Consumer Education.
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