BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24464261 · Received February 26, 2026

    Report

    Report Number
    1220648-2026-04174
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    D1. BRAND NAME UPDATED. H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. DEVICE IN WRONG POSITION: SINCE INSUFFICIENT CLINICAL INFORMATION WAS PROVIDED AND THE PUMP WASN'T RETURNED FOR INVESTIGATION, THE CAUSE OF THE DEVICE IN WRONG POSITION COULD NOT BE DETERMINED. DEVICE ALARM SYSTEM: SINCE NEITHER DATA LOGS NOR PRODUCT WERE AVAILABLE FOR INVESTIGATION, THE CAUSE OF THE DEVICE ALARM SYSTEM ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE CPSA GENERATED CONSECUTIVE ¿VENTRICLE¿ AND ¿AORTA¿ ALARMS WHILE DECREASING THE P-LEVEL. A BEDSIDE ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED THAT THE PUMP REMAINED REVEALED ACROSS VALVE. THE IMPELLA WAS ADVANCED, RESULTING IN RESOLUTION OF THE ALARMS. THE PUMP WAS SUCCESSFULLY WEANED AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281983 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025565245 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1