Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-

FDA device recall Z-1655-2026 · posted 2026-03-27 · Open, Classified

Recall details

Recalling firm

ReCor Medical Inc.

Reason for recall

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

Action taken

On 01/28/2026, the firm informed customers verbally and sent via mail an "MEDICAL DEVICE RECALL" Letter that nonconforming products (cracking in the hub adjacent to the guidewire port) that may lead to fluid leaks and could trigger a pressure error. Customers are instructed to: 1. Do not use the affected catheters for any patient procedures. 2. Identify the catheters from the affected lot and return to Recor Clinical Specialist through RMA process. 3. Review and complete the Acknowledgement and Receipt Form and provide to the Recor Clinical Specialist. For questions or further assistance - contact Director of Regulatory & Quality Compliance at Lisa.luu@recormedical.com or telephone at 650-542-7700

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QYI

Quantity affected

24

Distribution

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

Date initiated

2026-01-29

Date posted

2026-03-27

Location

Palo Alto, CA