BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25246742 · Received May 21, 2026

    Report

    Report Number
    1220648-2026-08102
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 58-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY. THE PATIENT HAD A HISTORY OF DIABETES MELLITUS. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. DURING SUPPORT, A CONTROLLER ERROR ALARM WAS REPORTED AND THE AUTOMATED IMPELLA CONTROLLER (AIC) INSTRUCTED THE TEAM TO SWITCH TO A NEW CONSOLE. THE TEAM PROCEEDED TO SWITCH TO A NEW AUTOMATED IMPELLA CONTROLLER, WHICH SUCCESSFULLY RESOLVED THE ALARM. THE PATIENT TOLERATED THE AIC TO AIC TRANSFER AND THE OLD AUTOMATED IMPELLA CONTROLLER WAS SET ASIDE TO BE SENT BACK FOR DIAGNOSTICS. THE DEVICE IS BEING CONSERVATIVELY REPORTED FOR DELAY OF THERAPY DUE TO THE TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT. THE PATIENT SURVIVED TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194981 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1144661 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male