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ReCor Medical Inc.: Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Des

Medical DevicesSource: FDA (device) · Date: 2026-04-08

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ReCor Medical Inc.
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
Reason / hazard
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Recall initiated
2026-01-29
Code info
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
Product quantity
24
Voluntary mandated
Voluntary: Firm initiated
City
Palo Alto
State
CA
Country
United States
Event id
98365
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