BEUDAMED
    FDA Enforcement Class I Ongoing

    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

    Recall: Z-1731-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1731-2015
    Event ID
    71239
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HeartWare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2015
    Initiation Date
    April 29, 2015
    Classification Date
    June 12, 2015
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

    Reason

    Complaints with the HVAD Internal Controller Alarm Battery failures.

    Code Info

    Serial #: ALL HeartWare HVAD systems currently in use.

    Distribution

    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.

    Quantity

    3,747 curently implanted