BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24147908 · Received January 22, 2026

    Report

    Report Number
    1220648-2026-01309
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    January 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION REPORT TO CAPTURE CODING CHANGES RELATED TO 1220648-2026-01309-1.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THE DEVICE WENT TO THE HOSPITAL PATHOLOGY DEPARTMENT WHICH IS AWARE TO HOLD THE DEVICE FOR IT TO BE RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE REPORT OF 1220648-2026-02117. ALL FUTURE INFORMATION WILL BE REPORTED UNDER REPORT 1220648-2026-02117.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: A 43-YEAR-OLD FEMALE WITH CARDIOMYOPATHY WAS SUPPORTED WITH AN IMPELLA CP (B)(4), GU CASE (B)(6) IMPLANTED ON (B)(6) 2025 AT 10:30 AM VIA A RIGHT SURGICAL AXILLARY/SUBCLAVIAN ARTERIAL ACCESS. ON (B)(6) 2026, PLASMA FREE HEMOGLOBIN (PFHGB) MEASURED 90 MG/DL, DECREASED FROM 100 MG/DL THE PREVIOUS DAY. THE TREATING INTENSIVIST ATTRIBUTED THE TRANSIENT ELEVATION IN PFHGB TO INTRAVASCULAR VOLUME DEPLETION, AND THE PATIENT WAS SUBSEQUENTLY ADMINISTERED IV FLUIDS. THERE WERE NO BLEEDING COMPLICATIONS. THE PATIENT LATER UNDERWENT AN ORTHOTOPIC HEART TRANSPLANT, AT WHICH TIME THE IMPELLA WAS SUCCESSFULLY EXPLANTED. THE PATIENT SURVIVED THE PROCEDURE, AND THE DEVICE IS AVAILABLE FOR RETURN. THE REPORTED FAILURE MODE WAS HEMOLYSIS. THE TRANSIENT ELEVATION IN PLASMA FREE HEMOGLOBIN WAS MEDICALLY ATTRIBUTED TO VOLUME DEPLETION RATHER THAN A CONFIRMED DEVICE MALFUNCTION. HEMOLYSIS IS CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210339 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026782080 813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention