BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23953638 · Received January 3, 2026

    Report

    Report Number
    1220648-2026-00023
    Event Type
    Malfunction
    Date Received
    January 3, 2026
    Date of Event
    December 24, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT STAFF WAS ALERTED TO THE CONSOLE DISPLAY SHOWING ¿0.0¿ ON IMPELLA FLOW READINGS, ACCOMPANIED BY A SIGNIFICANT INCREASE IN PULMONARY ARTERY PRESSURES TO 203/187 MMHG, WHILE THE PULSATILE MOTOR CURRENT REMAINED. A STAT CHEST X-RAY AND TRANSESOPHAGEAL ECHOCARDIOGRAM WERE PERFORMED TO CONFIRM INLET AND OUTLET POSITIONING, WITH COLOR DOPPLER FLOW USED AS SECONDARY CONFIRMATION OF APPROPRIATE FLOW FROM THE OUTLET ABOVE THE PULMONIC VALVE. LABORATORY TESTS WERE DRAWN FOR TRENDING. THE CARDIAC SUPPORT CENTER TEAM WAS CONSULTED, AND FINDINGS INDICATED A FAILED SENSOR, AS THE CONSOLE DISPLAYED ¿IMPELLA FLOW UNRELIABLE¿ AND SHOWED A HASHED PULMONARY ARTERY SIGNAL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITHOUT SUCTION ALARMS, AND LABORATORY VALUES AND URINE OUTPUT CONFIRMED THE ABSENCE OF HEMOLYSIS. THE PATIENT WAS WELL-SUPPORTED, AND THE PHYSICIAN WAS UPDATED IN PERSON. A REQUEST WAS MADE TO SEND THE PUMP TO ENGINEERING AND SCHEDULE A MEETING WITH THE ENGINEERING TEAM TO REVIEW THE DEVICE SENSOR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14897 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 IMPELLA RP FLEX 2025562137 813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male