BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25240498 · Received May 21, 2026

    Report

    Report Number
    1220648-2026-08055
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    October 12, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 56-YEAR-OLD FEMALE PATIENT PRESENTING WITH CARDIOMYOPATHY. THE REGISTERED NURSE REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) DID NOT REGISTER THE PURGE DISC, DESPITE CHANGING MULTIPLE CASSETTES. AFTER SWITCHING TO ANOTHER AIC, THE OPTICAL SENSOR WAS NOT READING ON THE CONSOLE. ECHOCARDIOGRAPHY WAS PERFORMED TO CONFIRM DEVICE POSITION, WHICH WAS FOUND TO BE APPROPRIATE, WITH FLOWS AND MOTOR CURRENT WITHIN NORMAL LIMITS FOR THE PERFORMANCE LEVEL. THE DEVICE WAS TAKEN TO BIOMED TO BE SENT BACK TO HEADQUARTERS FOR DIAGNOSTICS. A PLACEMENT SIGNAL NOT RELIABLE ALARM WAS PRESENT; ECHOCARDIOGRAPHY AGAIN CONFIRMED APPROPRIATE POSITION PER THE MANAGING PHYSICIAN. FLOW WAS NO LONGER READING ON THE SCREEN, BUT MOTOR CURRENT AND PURGE PRESSURES REMAINED WITHIN NORMAL LIMITS. ADDITIONAL PRECAUTIONS WERE DISCUSSED DUE TO CONCERN ABOUT THE ABSENCE OF VISIBLE ALARMS. DATA LOGS FROM THE CONTROLLER WERE SENT BACK FOR MAINTENANCE DUE TO THE INABILITY TO DETECT THE PURGE CASSETTE. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180327 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1117649 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female