BEUDAMED
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    Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code LOZ·June 13, 2008

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code LOZ·August 6, 2015

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Recall
    Completed ·SynCardia Systems LLC·Product code LOZ·August 1, 2023

    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code LOZ·October 21, 2016

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    FDA Recall
    Open, Classified ·SynCardia Systems LLC·Product code LOZ·November 2, 2022

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·October 26, 2016

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 12, 2016

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 7, 2016

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 20, 2016

    SYNCARDIA FREEDOM HOME AC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 19, 2016

    SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 19, 2016

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 2, 2016

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·October 3, 2016

    SYNCARDIA COMPANION HOSPITAL CART

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·November 18, 2016

    SYNCARDIA

    FDA Adverse Event
    Death ·SYNCARDIA·Product code LOZ·October 4, 2016

    SYNCARDIA FREEDOM ONBOARD BATTERY

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 19, 2016

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 1, 2016

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 1, 2015

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·August 11, 2015

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 20, 2015