BEUDAMED
    FDA Enforcement Class II Terminated

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Recall: Z-1813-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1813-2013
    Event ID
    65328
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    HeartWare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    May 16, 2013
    Classification Date
    July 29, 2013
    Termination Date
    August 5, 2019
    Address
    14400 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Reason

    Potential to electrostatic discharged (ESD)

    Code Info

    US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS

    Distribution

    Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.

    Quantity

    76 (US) and 82 (International)