BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24321334 · Received February 12, 2026

    Report

    Report Number
    1220648-2026-02964
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    October 30, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1 WAS REVISED. H6 UPON REVIEW BY THE INVESTIGATION TEAM, CODES E0514, E060109, E060110 AND A140508 THAT WERE REPORT ON THE INITIAL REPORT WERE REPORTED INCORRECTLY AND WERE REMOVED.

    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

    B5 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    D9 DEVICE WAS RETURNED AND DATE WAS ADDED. H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS WERE UPDATED ACCORDINGLY BASED ON DEVICE BEING RECEIVED. 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.

    Description of Event or Problem · 0

    A 38-YEAR-OLD WHITE MALE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT AFTER EXPERIENCING MULTIPLE SHOCKS FROM A WEARABLE CARDIOVERTER-DEFIBRILLATOR. THE PATIENT HAD A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, RECENT CORONARY STENT PLACEMENT APPROXIMATELY TWO WEEKS PRIOR, A REPORTED LEFT VENTRICULAR EJECTION FRACTION OF 15 PERCENT, AND DIABETES MELLITUS. THE PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY AND WAS FOUND TO HAVE AN OCCLUDED LEFT ANTERIOR DESCENDING CORONARY ARTERY. CORONARY STENTS WERE PLACED. DURING THE PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION CARDIAC ARREST, AND AN IMPELLA DEVICE WAS PLACED FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO A TERTIARY MEDICAL CENTER. AFTER TRANSFER, THE IMPELLA PUMP WAS NOTED TO HAVE AN ACTIVE ¿AIR IN PURGE SYSTEM¿ ALARM. WAVEFORMS WERE OBSERVED THAT WERE INDICATIVE OF PUMP SATURATION. THE PUMP SUBSEQUENTLY FAILED. THE IMPELLA DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE SECOND DEVICE SHOWED LOW FLOW AND A FLAT MOTOR CURRENT DESPITE GOOD POSITION. THE DECISION WAS MADE TO EXPLANT THE PUMP AND A CLOT WAS FOUND ON MOTOR AND INLET OF IMPELLA. A THIRD DEVICE WAS INSERTED AND SUPPORT WAS CONTINUED IN THE SAME SESSION. FOLLOWING DEVICE REPLACEMENT, THE PATIENT WAS ADDITIONALLY ESCALATED TO A VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION FOLLOWING A VENTRICULAR TACHYCARDIA. AFTER MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA AND FIBRILLATION, TWO SESSIONS OF ABLATIONS WERE CARRIED OUT, IMPROVING RHYTHM STABILITY. THE PATIENT WAS SUCCESSFULLY WEANED OFF SUPPORT AND THE IMPELLA CP REMOVED AFTER 14 DAYS OF SUPPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED ADDITION INFORMATION UPON REQUEST: "THE PUMP WAS REMOVED AND EXCHANGED DUE TO PUMP SATURATION FOLLOWED BY PUMP STOP. THE PUMP IS NOT AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382139 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026717732 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention