BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURION DEVICE

    MDR report key: 24761882 · Received April 2, 2026

    Report

    Report Number
    3011299930-2026-00002
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 2, 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

    HYPERINFLATION OF THE DEVICE MAY BE ASSOCIATED WITH THE ISOLATION OF LACTOBACILLUS ACIDOPHILUS/GASSERI, WHICH WAS IDENTIFIED FOLLOWING CULTURING OF THE FLUID FROM INSIDE THE INTRAGASTRIC BALLOON DURING THE ENDOSCOPIC REMOVAL. THESE FERMENTATIVE ORGANISMS ARE KNOWN TO PRODUCE GAS AS A METABOLIC BYPRODUCT, WHICH MAY INCREASE INTERNAL PRESSURE AND CONTRIBUTE TO VOLUMETRIC EXPANSION OF THE DEVICE. THIS FINDING MAY PROVIDE A POTENTIAL EXPLANATION FOR THE OBSERVED DEVICE HYPERINFLATION. HOWEVER, LACTOBACILLUS SPECIES ARE PART OF THE NORMAL GASTROINTESTINAL FLORA, AND THE SOURCE OF THE ORGANISM COULD NOT BE CONFIRMED, INCLUDING THE POSSIBILITY OF EXTERNAL CONTAMINATION. THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER AND HAS BEEN REQUESTED. FURTHER EVALUATION IS PENDING THE RETURN 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 PERSISTENT ABDOMINAL PAIN AND COMPLETE INTOLERANCE TO ORAL INTAKE. AN ABDOMINAL X-RAY PERFORMED ON (B)(6) 2026 WHICH SHOWED THAT THE DEVICE WAS HYPERINFLATED. 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
    829825 ALLURION DEVICE GASTRIC BALLOON LTI ALLURION TECHNOLOGIES, INC. 10D-CE 309191-1 00810010540317

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention