BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23991842 · Received January 7, 2026

    Report

    Report Number
    1220648-2026-00221
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    January 2, 2026
    Report Date
    January 14, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502013344
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE: A150206 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Additional Manufacturer Narrative · 0

    D9 UPDATED; THE PRODUCT HAS BEEN RETURNED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE UNKNOWN. 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

    IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPELLA CP THE SHEATH KINKED AFTER THE DILATOR WAS REMOVED AND THE IMPELLA COULD NOT ADVANCE. IMPLANTATION OF THE IMPELLA PUMP WAS ABORTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52642 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026760224 813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male