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Medtronic, Inc. is recalling HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail. When this occurs, batteries with an electrical fault may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
Health care providers with questions about this recall should contact their local Medtronic Representative. Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday-Friday, 8 a.m. to 5 p.m. Central time).
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