FDA recall Z-1655-2026

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-01-29

Report date

2026-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palo Alto, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1655-2026