June 4, 2018

FDA: Class I recall of HeartWare HVAD system by Medtronic

By: Judy Mathias

Editor’s Note

The Food & Drug Administration on June 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system as Class I, the most serious.

The recall was initiated because of the possibility for an interruption to occur in the electrical connection between the system’s power source and the HVAD controller.

Interruptions to the connection could cause the pump to stop, which could lead to exacerbation of heart failure symptoms, dizziness, anxiety, nausea, loss of consciousness, or death.

Manufacturing and distribution dates are March 2006 to May 2018.


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