Troubles Persist For Medtronic’s HeartWare Device As FDA Announces Another Class I Recall
It’s the third high-risk class I action in recent weeks related to the company’s HeartWare Ventricular Assist Device (HVAD) System. It’s also Medtronic’s sixth overall class I since the beginning of March.
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The Bio-Console 560 extracorporeal blood pumping console is being recalled over reports it could lose power during bypass surgery, which could lead to organ or neural dysfunction, blood clots, or even death.
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.