BEUDAMED
    FDA Recall Open, Classified

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    Recall: Z-1751-2015 · Initiated April 29, 2015

    Recall

    Recall Number
    Z-1751-2015
    Event Number
    71241
    Firm
    HeartWare Inc
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 29, 2015
    Posted
    June 10, 2015
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    Reason

    Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.

    Distribution

    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, Foreign: 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, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK,

    Quantity

    3,747 currently in use