BEUDAMED
    FDA Recall Terminated

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Recall: Z-1813-2013 · Initiated May 16, 0013

    Recall

    Recall Number
    Z-1813-2013
    Event Number
    65328
    Firm
    HeartWare Inc
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 16, 0013
    Posted
    July 29, 2013
    Terminated
    August 5, 2019
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Reason

    Potential to electrostatic discharged (ESD)

    Action

    HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to [email protected]. Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.

    Distribution

    Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.

    Quantity

    76 (US) and 82 (International)