• FDA categorizes TAVR delivery system recall as Class I

    6 monthes ago - By Healio

    The FDA announced it has classified Edwards Lifesciences' voluntary recall of a transcatheter heart valve delivery system as a Class I recall, the most serious kind.
    The delivery system is used to deliver a balloon-expandable transcatheter heart valve in transcatheter aortic valve replacement procedures, according to an alert from the FDA.
    The recall applies to model/item numbers 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A, 9600SDS20A, 9600SDS23A, 9600SDS26A and 9600SDS29A, manufactured from November 22, 2016 to July 10, 2017 and distributed
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