BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 24102096 · Received January 16, 2026

    Report

    Report Number
    1220648-2026-00968
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PPAE (MAJOR BLEED): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1983804 DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED AND NO DEVICE WAS RETURNED. INVESTIGATION SUMMARY: PPAE/MAJOR BLEED/EPISTAXIS: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF THE HEMOLYSIS WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT/DATA LOGS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 0

    SECTION H CODES HAVE BEEN UPDATED BASED ON ADDITIONAL INFORMATION. THIS REPORT REFLECTS THE MOST UP TO DATE CODING. CLINICAL ASSESSMENT: A 66-YEAR-OLD PATIENT PRESENTS IN ACUTE DECOMPENSATED CARDIOMYOPATHY CARDIOGENIC SHOCK WITH PREVIOUSLY KNOWN CORONARY ARTERY DISEASE/RENAL DISEASE, AND HISTORY OF NOSEBLEEDS DEVELOPED A NOSEBLEED WHILE ON IMPELLA 5.5 THERAPY. HEPARIN THERAPY WAS PLACED ON HOLD, AND NO FURTHER INFORMATION WAS PROVIDED. A COMPLAINT REGARDING THE NOSEBLEED WAS FILED. THE PATIENT WAS SUCCESSFULLY BRIDGED TO A LEFT VENTRICULAR ASSIST DEVICE. THE HEPARIN THERAPY MAY HAVE CONTRIBUTED TO THE PRE-EXISTING TENDENCY FOR NOSEBLEEDS. THE CASE WAS CODED AS EPISTAXIS AND SERIOUS INJURY. ADDITIONALLY, IT WAS NOTED ON THE THIRD DAY OF SUPPORT, THAT PLASMA FREE HEMOGLOBIN ROSE TO OVER 300, WHEN PREVIOUSLY PLASMA FREE HEMOGLOBIN LEVELS WERE IN THE 20S. THIS IS ALSO INDICATIVE OF HEMOLYSIS. ENGINEERING ASSESSMENT: DURING IMPELLA 5.5 PUMP SUPPORT, THE PATIENT EXPERIENCED A POTENTIAL MECHANICAL INTERACTION WITH BLOOD FROM THE PUMP AS PLASMA FREE HEMOGLOBIN ROSE TO OVER 300, WHEN PREVIOUSLY PLASMA FREE HEMOGLOBIN LEVELS WERE IN THE 20S. THIS WAS INDICATIVE OF HEMOLYSIS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A 5.5 PUMP. THE COMPLAINANT REPORTED A PATIENT WITH A NOSEBLEED. HEPARIN WAS PUT ON HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400304 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026754459 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1