BEUDAMED
    FDA Recall Terminated

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Recall: Z-1323-2013 · Initiated December 27, 2012

    Recall

    Recall Number
    Z-1323-2013
    Event Number
    64390
    Firm
    Heartware Inc
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 27, 2012
    Posted
    May 14, 2013
    Terminated
    July 9, 2013
    Address
    14000 NW 57th Ct, Miami Lakes, FL, 33014-3105

    Description

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    Reason

    HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.

    Action

    HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.

    Quantity

    3,544