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

Code information: Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862

Distribution pattern: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.