Recall Z-1655-2026
ReCor Medical Inc. · initiated January 29, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
Reason for recall
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-1655-2026
- Initiated
- January 29, 2026
- Posted by FDA
- March 27, 2026
- Product code
- QYI – Ablation Catheter, Renal Denervation
- Quantity
- 24
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
- Recalling firm
- ReCor Medical Inc., Palo Alto, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1654-2026 Class II | Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter…Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | 01/29/2026Open, Classified |