BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

    Recall: Z-1655-2026 · Initiated January 29, 2026

    Recall

    Recall Number
    Z-1655-2026
    Event Number
    98365
    Firm
    ReCor Medical Inc.
    FEI Number
    3010024164
    Product Code
    QYI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 29, 2026
    Posted
    March 27, 2026
    Address
    1049 Elwell Ct, Palo Alto, CA, 94303-4308

    Description

    Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

    Reason

    Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

    Action

    On 01/28/2026, the firm informed customers verbally and sent via mail an "MEDICAL DEVICE RECALL" Letter that nonconforming products (cracking in the hub adjacent to the guidewire port) that may lead to fluid leaks and could trigger a pressure error. Customers are instructed to: 1. Do not use the affected catheters for any patient procedures. 2. Identify the catheters from the affected lot and return to Recor Clinical Specialist through RMA process. 3. Review and complete the Acknowledgement and Receipt Form and provide to the Recor Clinical Specialist. For questions or further assistance - contact Director of Regulatory & Quality Compliance at [email protected] or telephone at 650-542-7700

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.

    Quantity

    24