BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23888314 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49272
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    September 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ==> NO PRODUCT WAS RETURNED. DEVICE IN WRONG POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS DETERMINED TO BE AN UNINTENTIONAL USE ERROR AS THE PUMP WAS IMPROPERLY POSITIONED VIA ECHO WHILE IN CCL. DEVICE HISTORY LOT ==> DEVICE LOT: 1955272 DEVICE HISTORY BATCH ==> SUBCOMPONENT LOT: . DEVICE HISTORY REVIEW ==> DEVICE (SN:(B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN IMPELLA CP PUMP WAS IMPLANTED TO SUPPORT A PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. DURING PLACEMENT IN THE CARDIAC CATHETERIZATION LABORATORY, THE DEVICE WAS IMPROPERLY POSITIONED UNDER ECHOCARDIOGRAPHIC GUIDANCE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE IMPELLA, BUT THE DEVICE WAS PULLED BACK TOO FAR AND COULD NOT BE ADVANCED ACROSS THE AORTIC VALVE. THE DECISION WAS MADE TO PLACE A NEW IMPELLA DEVICE. THE PATIENT WAS SUCCESSFULLY WEANED FROM IMPELLA SUPPORT, AND THE ORIGINAL DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453232 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026714078 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male