Paradise® Catheter PRDS-065-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810008950012), received between Oct 29, 2024 and Jul 16, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Use of Device Problem

  EVENT: RENAL ARTERY DISSECTION EVENT DESCRIPTION: A 66-YEAR-OLD FEMALE UNDERWENT A URDN PROCEDURE ON (B)(6) 2026. PRE-PROCEDURAL ANGIOGRAM AND IVUS IDENTIFIED AN OSTIAL ABNORMALITY IN THE RIGHT RENAL ARTERY (RRA) SUSPECTED TO BE FIBROMUSCULAR DYSPLASIA (FMD), A KNOWN CONTRAINDICATION OF URDN PROCEDURE. HOWEVER, DESPITE THIS THE PHYSICIAN DECIDED TO PROCEED WITH URDN PROCEDURE BECAUSE AS PER PHYSICIAN POTENTIAL BENEFITS OUTWEIGHED THE RISKS FOR THE PATIENT. PROCEDURE COMPLETED WITHOUT ANY DEVICE MALFUNCTION. POST-PROCEDURE ANGIOGRAPHY OF RRA REVEALED SLOW FLOW, SEVERE VASOSPASM, AND A DISSECTION AT THE LOCATION WHERE NO SONICATION WAS PROVIDED. NITROGLYCERINE WAS ADMINISTERED AND A STENT WAS SUBSEQUENTLY PLACED IN THE PROXIMAL TO MID RRA. ON (b)(6) 2026, SAME DAY AS THE PROCEDURE, THE EVENTS WERE RESOLVED AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. ACCORDING TO THE TREATING PHYSICIAN, THE FMD-AFFECTED SEGMENT GOT WORSENED PROBABLY DUE TO POTENTIAL DEEP SEATING OF THE MEDTRONIC 7F IMA GUIDE CATHETER OR MANIPULATION OF THE PARADISE CATHETER WHICH COULD HAVE LED TO THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 25846167 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: RENAL ARTERY DISSECTION. EVENT DESCRIPTION: TWO DISSECTIONS WERE IDENTIFIED IN DISTAL SEGMENT OF LEFT RENAL ARTERY. THE DISTAL SEGMENT WAS TREATED SUCCESSFULLY BY STENTING. POST-PROCEDURE VITALS WERE STABLE, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Vascular Dissection

  MAUDE report 23472497 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: RENAL ARTERY DISSECTION EVENT DESCRIPTION: SUBJECT UNDERWENT PROCEDURE ON (B)(6) 2025. AFTER COMPLETING TREATMENT IN THE LEFT MAIN RENAL ARTERY, CINE NOTED A LESION WHICH WAS INITIALLY SUSPECTED TO BE SPASM AS PER PHYSICIAN. RIGHT RENAL ARTERY WAS TREATED WITH NO ISSUES. AFTER COMPLETING BILATERAL TREATMENT, ANGIOGRAM NOTED A FLOW-LIMITING DISSECTION IN THE LEFT RENAL ARTERY (LRA) AT THE MOST DISTAL LOCATION WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AND STENTING. POST-PROCEDURE VITALS WERE STABLE, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. AS PER PHYSICIAN, UNIQUE ANATOMY WITH RENAL ARTERY TORTUOSITY WHICH MAY CAUSE POTENTIAL STRAIGHTENING AND/OR DISSECTION FROM ANY DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 23059671 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: HYPERTENSIVE CRISIS 46-YEAR-OLD FEMALE ENROLLED IN THE GPS REGISTRY ON 03 SEP 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION SINCE 2014 (LAST EPISODE OF HYPERTENSIVE CRISIS ON 10 OCT 2023), TYPE-II DIABETES, STROKE ON (B)(6) 2024 AND COILING OF ANTERIOR COMMUNICATING ARTERY ANEURYSM. SUBJECT WAS ON 4 ANTI-HTN MEDICATIONS (BISOPROLOL 5 MG, TRANDATE 200MG, SPIRONOLACTONE 25MG AND FELODIPINE 10MG) AT THE TIME OF CONSENT. ON (B)(6) 2024, THE SUBJECT UNDERWENT RENAL DENERVATION PROCEDURE, AND THE PROCEDURE WAS UNEVENTFUL. ON (B)(6) 2024, 03 DAYS POST-PROCEDURE, SUBJECT PRESENTED TO HOSPITAL WITH COMPLAINTS OF THUNDERCLAP OCCIPITAL HEADACHE AND LEFT EYE BLURRING, RESULTING IN HOSPITALIZATION. ON THE SAME DAY, CT HEAD AND CT ANGIOGRAM WERE PERFORMED, WHICH NOTED A COMPLETE OCCLUSION OF PREVIOUSLY COILED ANTERIOR COMMUNICATING ARTERY ANEURYSM. NO SIGNS OF ANEURYSMAL SUBARACHNOID HEMORRHAGE, ACUTE ISCHEMIC INFARCTION, STROKE OR HYDROCEPHALUS WERE NOTED. ON (B)(6) 2024, A LUMBAR PUNCTURE WAS PERFORMED WHICH SHOWED NO EVIDENCE OF SUBARACHNOID HEMORRHAGE. TH

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 20563648 ↗

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