BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24414640 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03792
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1. BRAND NAME UPDATED.

    Additional Manufacturer Narrative · 0

    D9: UPDATED 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.

    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

    AN IMPELLA CP WAS INSERTED VIA LEFT FEMORAL ARTERY IN A 42-YEAR-OLD MALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. PRIOR TO IMPLANTING THE IMPELLA, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION, IN WHICH CP SUPPORT WAS INITIATED. ON DAY 1 OF SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND CARDIAC ARREST, REQUIRING CARDIOPULMONARY RESUSCITATION AND 2 CARDIOVERSIONS. THE CP POSITION WAS CONFIRM APPROPRIATE, MEASURING 3.9CM. ON DAY 3 OF SUPPORT, THE AUTOMATED IMPELLA CONTROLLER ALARMED FOR HIGH MOTOR CURRENT, IMMEDIATELY FOLLOWED BY ALARMS FOR PURGE SYSTEM BLOCKED AND PUMP STOP. THE PURGE LINE WAS CHECKED FOR BLOCKAGES, THEN SUPPORT PERSONNEL WAS CONTACTED TO TROUBLESHOOT THE PUMP STOP. ATTEMPTS TO RESTART AT P5, P2, AND AGAIN AT P2 AFTER TWO MINUTES WERE UNSUCCESSFUL TO RESTART THE PUMP. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LAB FOR DEVICE EXPLANT. PRIOR TO THE ALARMS, THE PATIENT HAD BEEN THERAPEUTIC ON HEPARIN WITH THE LOWEST ACTIVATED CLOTTING TIME (ACT) IN THE PAST 24 HOURS BEING 148. THE DEVICE HAD BEEN FUNCTIONING AT P4 AT 2-2.7 L/MIN, MOTOR CURRENT MEAN CHARTED IN 400S, PURGE FLOW 13-15CC, AND PURGE PRESSURE 348-520. THIS EVENT IS CONSERVATIVELY REPORTED AS TACHYCARDIA PROMPTED INTERVENTION, BUT THERE WAS NO LASTING HARM OR INJURY REPORTED. THE PUMP ISSUES AND ALARMS ARE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY AS IT PROMPTED PREMATURE EXPLANT, BUT THERE WAS NO INTERVENTION NEEDED AND NO LASTING HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272236 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027824609 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1