Brand Name: Paradise Ultrasound Renal Denervation System recallZ-1654-2026 · ReCor Medical Inc. · initiated Jan 29, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ReCor Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1654-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 29, 2026
- Posted by the FDA
- Mar 27, 2026
- Recalling firm
- ReCor Medical Inc.
- Quantity
- 1
- Product code
- QYI
- FDA submissions
- P220023
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Product 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
Code information (models, lots, serial numbers)
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Paradise® Catheter PRDS-068-02Recor Medical, Inc. · Ablation Catheter, Renal Denervation2 recalls0 reports
Other devices under the same FDA submission
4 devices cleared under P220023 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Paradise® Catheter PRDS-065-02Recor Medical, Inc. · Ablation Catheter, Renal Denervation4 reports
- Paradise® Catheter PRDS-066-02Recor Medical, Inc. · Ablation Catheter, Renal Denervation2 reports
- Paradise® Catheter PRDS-067-02Recor Medical, Inc. · Ablation Catheter, Renal Denervation2 reports
- Paradise® Catheter PRDS-064-02Recor Medical, Inc. · Ablation Catheter, Renal Denervation1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 98365).
- Z-1655-2026 · Open, ClassifiedBrand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter rena…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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