Reported Apr 8, 2026 · Ongoing

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number:…

ReCor Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ReCor Medical Inc. · 1049 Elwell Ct · Palo Alto, CA · 94303-4308

Is this the product you have?

  • Brand NameParadise¿ Ultrasound
  • Renal Denervation System Product NameParadise ¿
  • Catheter Model/Catalog NumberPRDS-068-02
  • Product DescriptionCommon
  • nameAblation catheter renal denervation
Lot codes and dates
  • Lot Code
    • Model No PRDS-068-02
    • UDI-DI 00810008950043
  • Lot NumberM4907
Amount recalled
1

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.