FDA Enforcement
Class II
Ongoing
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
Recall: Z-1654-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1654-2026
- Event ID
- 98365
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ReCor Medical Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- January 29, 2026
- Classification Date
- March 27, 2026
- Address
- 1049 Elwell Ct, Palo Alto, CA, 94303-4308, United States
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
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Code Info
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.
Quantity
1