BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23897224 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49443
    Event Type
    Death
    Date Received
    December 26, 2025
    Date of Event
    September 19, 2025
    Report Date
    December 26, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : DATA REVIEW: DATA LOGS SHOWED PUMP RAN WITHOUT ISSUE DURING SUPPORT. THERE WERE NO ALARMS TRIGGERED DURING THE CASE. THERE WERE NO MC SPIKES, ABNORMAL PS OR PURGE ISSUES OBSERVED DURING SUPPORT. MECHANICAL INTERACTION WITH BLOOD: PRODUCT WAS NOT RETURNED FOR REVIEW. THE CAUSE OF MECHANICAL INTERACTION WITH BLOOD WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW. DEVICE HISTORY LOT : DEVICE LOT #: 1760495. DEVICE HISTORY BATCH : SUBCOMPONENT LOT#: N/A. DEVICE HISTORY REVIEW : PUMP SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED HEMOLYSIS AND THE PUMP WAS REPOSITIONED. NO FURTHER INFORMATION WAS PROVIDED; HOWEVER, IT WAS LATER REPORTED THAT CARE WAS WITHDRAWN AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785897 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2024422240 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| D