Recall Z-1654-2026 ยท QYI Ablation Catheter, Renal Denervation
ReCor Medical Inc.
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
| Date | Mar 27, 2026 (initiated Jan 29, 2026) |
| Status | Open, Classified |
| Reason | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. |
| Root cause | Under Investigation by firm |
| 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 - |
| Quantity | 1 |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.