Paradise® Catheter PRDS-067-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810008950036), received between Dec 22, 2025 and Apr 1, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

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.

• InjuryApr 1, 2026Use of Device Problem

  EVENT: RENAL ARTERY DISSECTION. EVENT DESCRIPTION: 40 YR OLD MALE PATIENT UNDERWENT RENAL DENERVATION PROCEDURE ON (B)(6) 2026. AFTER SONICATION OF THE LEFT MAIN RENAL ARTERY, A DISSECTION WAS NOTED IN ONE OF THE BRANCHES OF LEFT MAIN RENAL ARTERY. IT WAS CONFIRMED THAT THE DISSECTION WAS CAUSED DUE TO INADVERTENT USE OF AN OVERSIZED BALLOON (7 MM BALLOON IN A 4.8 MM VESSEL) BECAUSE OF INACCURATE MEASUREMENT OF THE VESSEL DIAMETER FROM PRE-PROCEDURAL CT SCAN. TO MANAGE THE DISSECTION, AN ONYX BALLOON (MEDTRONIC) WAS INFLATED AT THE DISSECTION SITE FOR 3 MINS TO FACILITATE THE REAPPOSITION OF THE DISSECTION FLAP AND TO SUPPORT SPONTANEOUS SEALING OF THE DISSECTION. THE EVENT RESOLVED, PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON (B)(6) 2025 AFTER 24 HOURS OF OBSERVATION.

  Patient problems: Vascular Dissection

  MAUDE report 24754221 ↗
• 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 (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 COMPLICATIONS OR PATIENT INJURY/HARM WAS REPORTED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872054 ↗

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-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
• 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