Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS
Summary
The FDA issued a Class II for Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradis by ReCor Medical Inc.. Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use..
Details
Source
Device Recall
External ID
Z-1654-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
Quantity Affected: 1
Reason for Recall
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-29
Company
Palo Alto, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ReCor Medical Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ReCor Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ReCor Medical Inc. have FDA actions?
ReCor Medical Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1654-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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