BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 23603736 · Received November 20, 2025

    Report

    Report Number
    1220648-2025-48495
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 23, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE 140508 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Additional Manufacturer Narrative · 0

    H6: PER A REVIEW OF THE COMPLAINT FILE, OMITTED CODE A140505 AND ADDED A160105.

    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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THEY ENCOUNTERED PUMP FLOW ISSUES DURING IMPELLA 5.5 SUPPORT. IT WAS NOTED THAT THE MOTOR CURRENT WAS FLAT, AND TEAM HAD TURNED THE P-LEVEL DOWN TO P-2 TO WEAN AND POSSIBLY EXPLANT. WHEN REVIEWING THE MOTOR CURRENT AND AORTA PLACEMENT SIGNAL, IT WAS NOTED TO HAVE CAUSED AN ALARM OF PLACEMENT SIGNAL IN AORTA. WHEN THE INTENSIVIST CHANGED THE P-LEVEL FROM P-2 TO P-4, THE MOTOR CURRENT REMAINED FLAT WITH NO CHANGES. THE FLOW DID INCREASE. IT WAS DISCUSSED IF THERE COULD BE A POSSIBLE INGESTION AT THE INLET OR WITHIN THE CANNULA ITSELF VERSUS THE MOTOR OR PURGE PRESSURE AREA. THE PUMP WAS SUCCESSFULLY WEANED AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321724 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026730353 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1