Paradise® Catheter PRDS-066-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810008950029), received between Dec 22, 2025 and Dec 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (P220023); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Expiration Date Error; Expiration Date Error

  EVENT: EXPIRED DEVICE USED. EVENT DESCRIPTION: A PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2025 USING A PARADISE CATHETER THAT HAD EXPIRED ON 29 NOV 2025. THE PARADISE CATHETER WAS INSPECTED PRIOR TO USE AND THE PACKAGING AND SEAL WAS INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PROCEDURAL COMPLICATION OR PATIENT INJURY/HARM REPORTED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873903 ↗
• MalfunctionDec 22, 2025Expiration Date Error; Expiration Date Error

  A PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2025 USING A PARADISE CATHETER THAT HAD EXPIRED ON (B)(6) 2025. THE PARADISE CATHETER WAS INSPECTED PRIOR TO USE AND THE PACKAGING AND SEAL WAS INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PROCEDURAL COMPLICATION OR PATIENT INJURY/HARM REPORTED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P220023. One submission often covers many models, so check the product and lot details in each record.

• Z-1654-2026 · Jan 29, 2026 · Open, Classified
  Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter rena
• Z-1655-2026 · Jan 29, 2026 · Open, Classified
  Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter rena