Z-1654-2026Class II

Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog...

Name: Z-1654-2026 Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog...
Creator: ReCor Medical Inc.
Published: 2026-01-29
License: https://open.fda.gov/license/

Recor Medical / initiated 2026-01-29 / Open, Classified

FDA source

ReCor Medical Inc. began a recall of Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name... on 2026-01-29. FDA classified it as Class II and gives the reason as "Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1654-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-29
Posted: 2026-03-27
Recalling firm: Recor Medical
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
Product code: QYI Ablation Catheter, Renal Denervation
Reason for recall: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
FDA 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 - contact Director of Regulatory & Quality Compliance at [email protected] or telephone at 650-542-7700
Quantity in commerce: 1
Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Product codes and lots: Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1654-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1654-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1655-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code QYI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)