BEUDAMED
    FDA Enforcement Class I Ongoing

    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    Recall: Z-0006-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0006-2017
    Event ID
    74999
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HeartWare, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    August 17, 2016
    Classification Date
    October 13, 2016
    Address
    14400 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    Reason

    Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.

    Code Info

    All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.

    Distribution

    Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.

    Quantity

    344 pumps