BEUDAMED
    FDA Enforcement Class II Terminated

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Recall: Z-1323-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1323-2013
    Event ID
    64390
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heartware Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    December 27, 2012
    Classification Date
    May 14, 2013
    Termination Date
    July 9, 2013
    Address
    14000 NW 57th Ct, Miami Lakes, FL, 33014-3105, United States

    Description

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Reason

    HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.

    Code Info

    Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.

    Quantity

    3,544