BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 23675804 · Received November 29, 2025

    Report

    Report Number
    1220648-2025-48650
    Event Type
    Malfunction
    Date Received
    November 29, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDED TYPE OF INVESTIGATION CODE B11 H11: ADDED INFORMATION REGARDING THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY PUMP WAS NOT RETURNED FOR INVESTIGATION. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL INFORMATION. PRODUCT DAMAGE (ANTICONTAMINATION SLEEVE SPLIT/TORN): THE CAUSE OF THE STERILE SLEEVE DAMAGE ISSUE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL INFORMATION. DEVICE HISTORY LOT DEVICE BATCH:1964716 DEVICE HISTORY REVIEW THE PUMP (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT, IN OR POST 5.5 INSERTION, MD TRYING TO REPOSITION THE PUMP AND STERILE SLEEVE BROKE OFF. ADVISED MD TO COVER STERILE SLEEVE AND HANDOFF TO STAFF MANAGING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265721 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026734277 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male