BEUDAMED
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    HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·August 11, 2017

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·August 14, 2017

    HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC·Product code DSQ·August 2, 2017

    640G INSULIN PUMP MMT-1712K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 21, 2017

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·April 21, 2017

    ARCTIC SUN 5000

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·June 22, 2018

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2018

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 15, 2016

    SYNCARDIA FREEDOM AC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·May 9, 2016

    VASOVIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 14, 2020

    TARGET 360 SOFT 3MM X 6CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR CORK·Product code HCG·January 2, 2025

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 16, 2025

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 19, 2020

    VOCSN

    FDA Adverse Event
    Malfunction ·VENTEC LIFE SYSTEMS, INC.·Product code CBK·March 12, 2025

    DAVINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·February 21, 2025

    O-ARM O2 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·January 30, 2025

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 13, 2025

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 11, 2020

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·March 26, 2020

    ALARIS PC UNIT

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FRN·January 24, 2020