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 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA is providing updates to the FDA website to include information on recent recalls conducted by Medtronic. These recalls include information on battery performance issues as well as the availability of a modified software for select patients.
The FDA remains committed to providing updates about the safety profile of the HeartWare Ventricular Assist Device (HVAD) System.
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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