BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 24053233 · Received January 13, 2026

    Report

    Report Number
    1220648-2026-00588
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    November 20, 2025
    Report Date
    January 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 A PATIENT FAILED SPONTANEOUS BREATHING TRIAL (SBT) AND WAS UNABLE TO EXTUBATE. PATIENT UNDERGOING SUPRAVENTRICULAR TACHYCARDIA (SVT) AGAIN, BUT NOTED TO BE UNLIKELY TO PASS DUE TO EXCESSIVE SECRETIONS AND TACHYPNEA. THE PHYSICIAN ASSISTANT CONSULTED REGARDING PATIENT MANAGEMENT AND GOALS. POSSIBLE DEVICE-RELATED CONTRIBUTION TO VENTRICULAR TACHYCARDIA (VT) DURING SBT. LAST ECHOCARDIOGRAM SHOWED DEVICE POSITION REMAINED AT 5.3 CM. THE PUMP WAS SUBSEQUENTLY WEANED AND EXPLANTED. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116433 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 2026719774 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention