BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 29, 2015

    Recall

    Recall Number
    Z-1731-2015
    Event Number
    71239
    Firm
    HeartWare Inc
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 29, 2015
    Posted
    June 13, 2015
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    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.

    Action

    Urgent Medical Device Correction letters were sent to customers. The letter identified the affected product, as well as the reason for the recall and risks involved. HeartWare requests that customers review and familiarize themselves with the letter and "Patient Communication," and ensure that all necessary individuals are aware. Patients currently being supported by the device should be identified and given the "Patient Communication." A HeartWare representative can provide assistance with that process if needed. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of the receipt of the letter. Customers can contact their local HeartWare representative with questions or concerns. Clinical Support personnel are also available at 1-888-494-6365.

    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