Recall Of Medtronic’s HeartWare Pump Kits Labeled Class I By FDA; Deaths, Injuries Reported
The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.
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The US FDA on 12 April affixed its highest risk classification to a recall of certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) made by Medtronic. It’s the third class I recall for the medtech giant since 1 March.
The US FDA gave its highest risk classification to a recent recall of the Valiant Navion Thoracic Stent Graft System. Two serious injuries and one death – a clinical trial participant – were reported.
The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.