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U.S. Department of Health and Human Services

Class 2 Device Recall Paradise Ultrasound Renal Denervation System

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 Class 2 Device Recall Paradise Ultrasound Renal Denervation Systemsee related information
Date Initiated by FirmJanuary 29, 2026
Date PostedMarch 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1655-2026
Recall Event ID 98365
PMA NumberP220023 
Product Classification Ablation catheter, renal denervation - Product Code QYI
ProductBrand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Code Information Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
FEI Number 3010024164
Recalling Firm/
Manufacturer		 ReCor Medical Inc.
1049 Elwell Ct
Palo Alto CA 94303-4308
For Additional Information ContactLisa Luu
650-5427700
Manufacturer Reason
for Recall		Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce24
DistributionU.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = QYI
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