BEUDAMED
    FDA Enforcement Class I 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 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2052-2017
    Event ID
    76978
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thoratec Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    March 30, 2017
    Classification Date
    May 24, 2017
    Termination Date
    March 20, 2019
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270, United States

    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.

    Code Info

    Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.

    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