BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23960367 · Received January 5, 2026

    Report

    Report Number
    1220648-2026-00140
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 26, 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

    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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ASAE/HEMATOMA: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    E1 ADDED INITIAL REPORTER PHONE NUMBER AS THEY WERE OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED.

    Description of Event or Problem · 0

    ACCESS SITE OF THE IMPELLA AND MAC HAS A NOTABLE HEMATOMA THAT WAS SEEN AFTER THE PEELAWAY SHEATH WAS REMOVED. MANUAL PRESSURE HELD, FEMSTOP WAS PLACED AND NITRO DRIP WAS ADDED FOR BLOOD PRESSURE MANAGEMENT. BLOOD PRESSURE WAS HIGH >170/100/126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18258 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026734319 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention