Z-1655-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- January 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
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 for Recall
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Code Information
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862