BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23897333 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49470
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 20, 2025
    Report Date
    December 26, 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

    INVESTIGATION SUMMARY. NO PRODUCT WAS RETURNED FOR INVESTIGATION. CARDIAC TAMPONADE: THE CAUSE OF THE CLINICAL SYMPTOM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT. DEVICE LOT: 1954306. DEVICE HISTORY BATCH. SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW. DEVICE WITH SN:614357 PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT HAD A CARDIAC TAMPONADE OVERNIGHT AND TAKEN TO THE OPERATING ROOM FOR AN EMERGENCY WASH OUT, CHEST TUBES WERE EXCHANGED, AND THE CHEST WAS CLOSED. THE PUMP WAS SUCCESSFULLY WEANED AND EXPLANTED, AND THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344866 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026716146 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention