Paradise renal denervation catheter unit distributed despite scrapping designation
One Paradise Ultrasound Renal Denervation catheter was distributed although it was a nonconforming product that should have been scrapped and not used in humans.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide