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    LIVANOVA USA, INC.

    FDA Adverse Event
    Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·May 22, 2019

    LIVANOVA USA, INC. SMART PERFUSION PACK

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code DWE·July 7, 2020

    TUBING, PUMP, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DWE·July 7, 2021

    TUBING, PUMP, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DWE·November 11, 2020

    1/4 X 3/8 CONNECTOR

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DTL·October 28, 2021

    RAP FEMORAL VENOUS CANNULA

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC.·Product code DWF·April 25, 2026

    CUSTOM PERFUSION TUBING SET

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC·Product code DWE·February 21, 2019

    1/4 X 3/8 REDUCING CONNECTOR

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DTL·May 20, 2022

    SMARXT TUBING AND CONNECTORS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DWE·April 15, 2021

    COBE SMARXT TUBING AND CONNECTORS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC.·Product code DWE·July 31, 2024

    1/4 X 3/8 CONNECTOR

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DTL·October 28, 2021

    TUBING

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC.·Product code DWE·May 7, 2024

    PULSE GEN MODEL 106

    FDA Adverse Event
    Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·December 29, 2022

    FAIRFIELD MED CTR OH 1

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC.·Product code DWE·November 21, 2025

    COBE SMARXT TUBING AND CONNECTORS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DWE·April 14, 2022

    SMARXT TUBING AND CONNECTORS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DWE·June 22, 2021

    SMART TUBING AND CONNECTORS

    FDA Adverse Event
    Malfunction ·LIVANOVA USA INC·Product code DWE·October 21, 2021

    PULSE GEN MODEL 1000

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·November 14, 2025

    CARDIOPLEGIA ADAPTER CANNULA

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC·Product code DWF·February 6, 2019

    PULSE GEN MODEL 1000

    FDA Adverse Event
    Death ·LIVANOVA USA, INC.·Product code LYJ·December 16, 2022