BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23559001 · Received November 14, 2025

    Report

    Report Number
    1220648-2025-48376
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    April 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, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. VENTRICULAR TACHYCARDIA: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1885263 DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT HAD A MONTH LONG OF IMPELLA 5.5 PUMP SUPPORT FOR CARDIOGENIC SHOCK AND CARDIOMYOPATHY. THE PATIENT WAS EXPLANTED AND TRANSPLANTED AND SURVIVED. THE LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) IMPELLA REGISTRY REPORTED MONTHS LATER REPORTED UPON THE ADVERSE EVENT OF THE VENTRICULAR TACHYCARDIA TREATED WITH MEDICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563175 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025608691 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention