Separate safety issues have lead Medtronic PLC and Abbott Laboratories Inc. to issue class I recalls on ventricular assist device products used to treat heart failure patients in recent weeks. Class I recalls are the most serious type, and indicate there is a risk of serious adverse events or death.
FDA designated a Medtronic recall of its HeartWare VAD System due to unexpected power-source switching as a class I action on June 1. The electrical connection between the HeartWare...
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