BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23581929 · Received November 18, 2025

    Report

    Report Number
    1220648-2025-48428
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 19, 2025
    Report Date
    December 31, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TACHYCARDIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. MAJOR BLEED: THE CAUSE OF THE INJURY WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND INSUFFICIENT CLINICAL DETAILS PROVIDED. DEVICE HISTORY LOT: DEVICE LOT: 1911465. DEVICE HISTORY BATCH: SUB-COMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP S/N: (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 EXPERIENCED VENTRICULAR TACHYCARDIA AND BLEEDING. THE PATIENT WAS TRANSFUSED ONE UNIT OF PACKED RED BLOOD CELLS. LATER, THE PATIENT WAS SUCCESSFULLY WEANED FROM THE PUMP AND SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237228 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026657621 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention