BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURION DEVICE

    MDR report key: 24797309 · Received April 7, 2026

    Report

    Report Number
    3011299930-2026-00003
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ALLURION TECHNOLOGIES, INC.
    Product Code
    LTI
    UDI-DI
    00810010540317
    PMA / PMN Number
    P250023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THAT THE BALLOON IMPLANTED ON (B)(6) 2026 WAS FROM LOT NUMBER 308757-1, WITH AN EXPIRATION DATE OF 17-JAN-2026; THEREFORE, THE DEVICE WAS USED BEYOND ITS LABELED EXPIRATION DATE. ADDITIONALLY, THE DEVICE WAS IMPLANTED IN A PATIENT WITH A BMI OF 26.6, WHICH IS BELOW THE SPAIN-APPROVED MINIMUM BMI OF 27. THE DEVICE HAS BEEN REQUESTED FOR RETURN AND IS CURRENTLY AVAILABLE FOR RETRIEVAL. FURTHER EVALUATION WILL BE PERFORMED UPON RECEIPT AND ANALYSIS OF THE DEVICE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PLACEMENT OF THE ALLURION BALLOON ON (B)(6) 2026. THE PATIENT SUBSEQUENTLY REPORTED COMPLETE INTOLERANCE TO FOOD AND FLUID INTAKE AND PERSISTENT ABDOMINAL PAIN. AN ABDOMINAL X-RAY WAS PERFORMED ON (B)(6) 2026. PER THE PLACING PHYSICIAN, THE DEVICE WAS SHOWN TO BE HYPERINFLATED WITH NO EVIDENCE OF OBSTRUCTION. THE DEVICE WAS ENDOSCOPICALLY PUNCTURED AND REMOVED ON (B)(6) 2026. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859032 ALLURION DEVICE GASTRIC BALLOON LTI ALLURION TECHNOLOGIES, INC. 10D-CE 308757-1 00810010540317

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention