Class II
Medical Device Recall: 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
ReCor Medical Inc. · January 29, 2026
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.
States Affected
NATIONWIDE
Quantity Affected
1
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1654-2026
Status: ongoing
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