BEUDAMED
    FDA Enforcement Class I Ongoing

    HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    Recall: Z-1538-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1538-2017
    Event ID
    76600
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2017
    Initiation Date
    February 3, 2017
    Classification Date
    April 26, 2017
    Address
    14400 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    Reason

    Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)

    Code Info

    HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435 .

    Distribution

    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.

    Quantity

    8,343 US and 13,145 INTERNATIONAL