BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23872994 · Received December 22, 2025

    Report

    Report Number
    1220648-2025-49212
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODE A141204 BASED ON INFORMATION IN THE COMPLAINT FILE.

    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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: NO PRODUCT OR DATA LOGS WERE RETURNED FOR EVALUATION. DEVICE IN WRONG POSITION: CLINICAL DETAILS NOTED IMPELLA IN AORTA WHILE ON SUPPORT. THE CAUSE OF THE DEVICE IN WRONG POSITION COULD NOT BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED. HIGH PURGE PRESSURE/PURGE SYSTEM BLOCKED: CLINICAL DETAILS NOTED THAT PUMP HAD PURGE PRESSURE ISSUES ON DAY 17 OF SUPPORT. NO ADDITIONAL DETAILS PROVIDED. THE CAUSE OF THE HIGH PURGE PRESSURE/PURGE SYSTEM BLOCKED COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION AND LIMITED CLINICAL DETAILS WERE PROVIDED. PUMP STOP: CLINICAL DETAILS NOTED THAT PUMP STOPPED AFTER PURGE PRESSURE ISSUES WERE OCCURRING. NO ADDITIONAL DETAILS PROVIDED. THE CAUSE OF THE PUMP STOP COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION AND LIMITED CLINICAL DETAILS WERE PROVIDED. CLINICAL REVIEW: ON (B)(6) 2025: IMPELLA CP INSERTED VIA LEFT AXILLARY ARTERY. ON (B)(6) 2025: PURGE PRESSURE ISSUES NOTED UNTIL PUMP STOPPED. IMPELLA IN AORTA, P-LEVEL REDUCED TO P-0. PUMP WAS DISCONNECTED AND CONSOLE TURNED OFF. A NEW IMPELLA WAS INSERTED WITHOUT ISSUES. DEVICE HISTORY REVIEW: DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED OPTICAL ISSUES. THE PUMP WAS FOUND TO BE IN THE AORTA. THE P LEVEL OF THE PUMP WAS REDUCED AND THE CONSOLE WAS TURNED OFF. LATER, PURGE PRESSURE ISSUES OCCURRED. THE PUMP WAS EXPLANTED AND REPLACED WITH A NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318692 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026750321 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown