BEUDAMED
    FDA Recall Terminated

    HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

    Recall: Z-2052-2017 · Initiated March 30, 2017

    Recall

    Recall Number
    Z-2052-2017
    Event Number
    76978
    Firm
    Thoratec Corporation
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2017
    Posted
    May 24, 2017
    Terminated
    March 20, 2019
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

    Reason

    St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

    Action

    Urgent Medical Device Correction letters, dated March 29, 2017, were sent to customers. The letters provided information on what the current correction will involve to ensure patients are successfully able to exchange their pocket controller in an emergency situation. Patients will receive the updates at scheduled appointment. Questions regarding the notice, should be directed to Abbott HeartLine at 800-456-1477; or, your Abbott Sales Representative.

    Distribution

    Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    24,077 active units in US