Another Class I Recall For Medtronic, This Time For Defibrillators
Executive Summary
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.
You may also be interested in...
12 Deaths Prompt Another Class I Recall For Medtronic’s HeartWare – The Firm’s Fourth In Recent Weeks
The medtech giant has racked up yet another high-risk class I recall designation from the US FDA, this time for HeartWare Ventricular Assist Device (HVAD) cables and controller ports. It’s also the second class I recall action for the HeartWare device in a little more than six weeks, and the company’s fourth overall.
It’s Class I For Medtronic’s Valiant Navion Recall
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.
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.