BEUDAMED
    FDA Recall Terminated

    HeartWare Ventricular Assist System Controller 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. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    Recall: Z-0005-2017 · Initiated June 8, 2016

    Recall

    Recall Number
    Z-0005-2017
    Event Number
    72001
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 8, 2016
    Posted
    October 17, 2016
    Terminated
    March 31, 2020
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    HeartWare Ventricular Assist System Controller 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. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    Reason

    Loose connector ports in controller body.

    Action

    HeartWare sent an Urgent Medical Device Correction letter dated June 8, 2016, to all affected customers, HeartWare advised clinicians to remind patients to follow unit instructions and water avoidance, and to regularly schedule appointments to check the integrity of the unit and to be cautious with connectors when inspecting connectors. Clinicians were also instructed to send back the enclosed "Acknowledgement Form" within 30 days and to forward the message to necessary individuals within their organization. Customers with questions were instructed to contact their local HeartWare representative. For questions regarding this recall call 305-364-1575.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, 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 countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.

    Quantity

    4235 Worldwide, 7272 units in U.S.