BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24449193 · Received February 25, 2026

    Report

    Report Number
    1220648-2026-04052
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE CONTROLLER ERROR ALARM WAS A COMMUNICATION ANOMALY BETWEEN THE OPTICAL PRESSURE MEASURING UNIT AND THE MAIN COMPUTER.

    Additional Manufacturer Narrative · 0

    D9: UPDATED THE DEVICES RETURN INFORMATION . THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN AN 82-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE. DURING DEVICE SETUP, THE AIC DISPLAYED AN ALARM INDICATING THAT THE OPTICAL SENSOR WAS NOT DETECTED. THE CATHETER WAS INSPECTED, AND LIGHT WAS CONFIRMED THROUGH THE PLUG-IN AREA. AFTER RE-PLUGGING THE DEVICE, SETUP WAS COMPLETED SUCCESSFULLY. THE IMPELLA INITIALLY RAN NORMALLY WITHOUT ISSUES. APPROXIMATELY 20 MINUTES LATER, A CONTROLLER FAILURE ALARM OCCURRED, DURING WHICH THE AO AND LV WAVEFORMS DISAPPEARED, ALTHOUGH MOTOR CURRENT, FLOWS, AND PURGE PARAMETERS REMAINED STABLE WITH NO LOSS OF SUPPORT. THE CONTROLLER WAS EXCHANGED FROM AIC (B)(6) TO AIC (B)(6), AFTER WHICH THE DEVICE OPERATED NORMALLY WITH NO ALARMS. THERE WAS NO HARM OR LOSS OF SUPPORT DURING THE ALARM OR DURING THE CONTROLLER EXCHANGE. THE REPORTED EVENTS ARE CONTROLLER FAILURE, MEDICAL DEVICE REMOVAL, DEVICE REVISION OR REPLACEMENT, AND HEMODYNAMIC INSTABILITY. THE IMPELLA CP WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND SUPPORT WAS RESUMED WITHOUT ANY KNOWN ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511499 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1136985

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention