BEUDAMED
    FDA Enforcement Class II Terminated

    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266

    Recall: Z-2349-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2349-2019
    Event ID
    83357
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thoratec Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    August 28, 2019
    Initiation Date
    March 30, 2019
    Classification Date
    August 22, 2019
    Termination Date
    August 24, 2020
    Address
    6035 Stoneridge Dr, N/A, Pleasanton, CA, 94588-3270, United States

    Description

    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266

    Reason

    Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

    Code Info

    105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 50000000 and higher. UDI/GMDN 00813024013266 / 61747

    Distribution

    Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

    Quantity

    149 outflow graft units