BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24112180 · Received January 19, 2026

    Report

    Report Number
    1220648-2026-01087
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    November 18, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY- NO PRODUCT WAS RETURNED. UNABLE TO DELIVER OR ADVANCE: THE CAUSE OF THE DELIVER ISSUE WAS DETERMINED TO BE PATIENT CONDITION AS THE PATIENT HAD DIFFICULT ANATOMY PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY LOT- DEVICE LOT: 1994161. DEVICE HISTORY BATCH- SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW- DEVICE SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE IMPELLA COULD NOT BE ADVANCED DUE TO THE PATIENT¿S ANATOMY, RESULTING IN UNSUCCESSFUL PLACEMENT. THE IMPELLA INSERTION WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173559 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026774691 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male