BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 23872054 · Received December 22, 2025

    Report

    Report Number
    3010024164-2025-00005
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 22, 2025
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    UDI-DI
    00810008950036
    PMA / PMN Number
    P220023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT: EXPIRED DEVICE USED. EVENT DESCRIPTION: A PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2025 USING A PARADISE CATHETER THAT HAD EXPIRED ON (B)(6) 2025. THE PARADISE CATHETER WAS INSPECTED PRIOR TO USE AND THE PACKAGING AND SEAL WAS INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PROCEDURAL COMPLICATIONS OR PATIENT INJURY/HARM WAS REPORTED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209947 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. M4739 00810008950036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown