Class I VAD Units Recalls Continue From Abbott, Medtronic

HeartMate and Medtronic’s HeartWare ventricular assist device platforms have been tagged with class I recalls in the last few weeks based on separate safety issues.

The text Product Recall appearing behind torn brown paper
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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...

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