BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 23873792 · Received December 22, 2025

    Report

    Report Number
    3010024164-2025-00006
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 22, 2025
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    UDI-DI
    00810008950029
    PMA / PMN Number
    P220023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    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 COMPLICATION OR PATIENT INJURY/HARM REPORTED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703090 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. M4675 00810008950029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown