BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 24016579 · Received January 8, 2026

    Report

    Report Number
    1220648-2026-00356
    Event Type
    Death
    Date Received
    January 8, 2026
    Date of Event
    December 9, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AFTER THE IMPELLA WAS PLACED, DISTAL LIMB PULSES COULD NOT BE OBTAINED. THE PHYSICIAN WAS INFORMED AND ELECTED NOT TO INTERVENE DESPITE RECOMMENDATIONS FROM THE COMPLAINANT AND THE CRITICAL CARE PHYSICIAN. THE PUMP IS NOT AVAILABLE FOR RETURN AS IT WAS EXPLANTED AND DISPOSED OF. THE FAMILY ELECTED TO WITHDRAW CARE FOR THE PATIENT, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78008 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026774799 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Life Threatening| R| D