BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25125674 · Received May 8, 2026

    Report

    Report Number
    1220648-2026-07687
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    May 5, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 DEVICE WAS RETURNED AND DATE RECEIVED WAS ADDED. H6 TYPE OF INVESTIGATION CODE WAS UPDATED DUE TO THE DEVICE BEING RETURNED. H11 UPDATED ADDITIONAL MANUFACTURER NARRATIVE DUE TO DEVICE BEING RETURNED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR RETURN. 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 CP WAS BEING PRIMED FOR SUPPORT AND INSERTION VIA THE LEFT FEMORAL ARTERY TO SUPPORT THE 85 YEAR OLD FEMALE PATIENT WHO WAS ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE WITH PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION, PRESENTING IN SCAI STAGE D SHOCK. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP PUMP FAILED TO PRIME AND DESPITE ALL TROUBLESHOOTING MEASURES, INCLUSIVE OF PURGE CASSETTE REPLACEMENT, THE CP WAS REMOVED AND REPLACED WHEN IT FAILED TO PRIME. THE TEAM INSTEAD PLACED A NEW CP AND SUPPORT SUCCESSFULLY INITIATED. THE EXCHANGE OF PUMP WAS PERFORMED WITH NO CLINICAL CONSEQUENCE NOTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4732 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027879507 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1