FDA-Device2026-04-08Class II
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.
Hazard
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Sold states
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Affected count
1
Manufactured in
1049 Elwell Ct, Palo Alto, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1654-2026Original summary
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 Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907 Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA. Affected quantity: 1
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