BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23954267 · Received January 4, 2026

    Report

    Report Number
    1220648-2026-00045
    Event Type
    Injury
    Date Received
    January 4, 2026
    Date of Event
    December 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR SERVES AS A NOTIFICATION, IN WHICH MDR 1220648-2026-00045 WAS ERRONEOUSLY FILED AS A DUPLICATE OF MDR 1220648-2025-49750. PLEASE REFER TO MDR 1220648-2025-49750 FOR ALL REPORTS FILED FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE UNKNOWN. THE ROOT CAUSE OF THE ISCHEMIA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED ISCHEMIA IN THE LEFT LOWER EXTREMITY. AN EXTERNAL FEMORAL BYPASS WAS SCHEDULED TO RESTORE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026769340 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention