ReCor Medical Inc. recalls Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Cat…

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

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

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 Lisa.luu@recormedical.com or telephone at 650-542-7700

• FDA enforcement recordOfficial FDA database entry for Z-1654-2026
• FDA device classification · QYIOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ReCor Medical Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.