Paradise® Catheter PRDS-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810008950005), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT: RENAL ARTERY THROMBOSIS EVENT DESCRIPTION: A FEMALE PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, MULTIPLE ATTEMPTS WERE MADE TO ACCESS THE CHALLENGING, TORTUOUS LEFT RENAL ARTERY USING THREE DIFFERENT PARADISE BALLOONS, WHICH REPEATEDLY DISLODGED DUE TO RESISTANCE CAUSED BY VESSEL TORTUOSITY. PARADISE CATHETER WAS NEVER INFLATED NOR WAS ANY SONICATION PROVIDED THE LEFT RENAL ARTERY. ALTHOUGH THE RETURNED DEVICES HAD TEARS WHICH APPEARED TO BE DUE TO TORTUOUS ANATOMY, THIS IS HIGHLY UNLIKELY RELATED TO THE ADVERSE EVENT. AS PER PHYSICIAN, THE ANTICOAGULATION DOSE WAS INADEQUATE. POST PROCEDURAL RENAL ANGIOGRAM NOTED A CLOT PARTIALLY OCCLUDING THE LEFT RENAL ARTERY. THE CLOT WAS TREATED WITH UNILATERAL THROMBECTOMY USING PENUMBRA PUMP (CAT6) WHICH RESTORED THE BLOOD FLOW. FOLLOWING THE THROMBECTOMY PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE ICU. A CONTRAST-ENHANCED CT SCAN WAS PERFORMED NOTED AREAS OF INFARCTION IN THE LEFT KIDNEY. PATIENT CONDITION IMPROVED AND DISCHARGED UNDER STABLE CONDITION 3 DAYS LATER. SUBOPTIMAL ANTICOAGULATION DOSE ALONG WITH FORCED INSERTION OF PARADISE CATHETERS AGAINST CHALLENGING ANATOMY, ATHERO

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23812610 ↗

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