LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575640VRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741135385), received between Oct 31, 2018 and Oct 3, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT THREE MONTHS AND THIRTY DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF STENOSIS OF THE CEPHALIC VEIN WHICH REQUIRED AN ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE NEW LESION WITHIN THE ACCESS CIRCUIT IN THE LEFT FOREARM WAS SUCCESSFULLY TREATED WITH DRUG COATED BALLOON CATHETER. IT WAS ALSO REPORTED THAT SIX MONTHS AND THREE DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF STENOSIS OF THE CEPHALIC VEIN WHICH REQUIRED AN ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. FURTHERMORE, THE NEW LESION WITHIN THE ACCESS CIRCUIT IN THE LEFT FOREARM WAS SUCCESSFULLY TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINOUS ANGIOPLASTY BALLOON CATHETER. THE RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RECOVERED. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES REPORTED FOR THIS SUBJECT TO DATE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 17859489 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET APPROVAL STUDY DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION IN THE LEFT FOREARM CEPHALIC VEIN. APPROXIMATELY 150 DAYS POST INDEX PROCEDURE, THE TARGET LESION WAS REOCCLUDED. RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT. THE INVESTIGATOR ASSESSED THE REOCCLUSION EVENT WAS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 8942417 ↗
• MalfunctionOct 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT NOMINAL PRESSURE WHILE TREATING THE TARGET LESION IN THE AV FISTULA. THE HEALTH CARE PROFESSIONAL (HCP) DISCARDED THE LUTONIX DCB AND IT IS NOT AVAILABLE FOR EVALUATION. ALTHOUGH REQUESTED MULTIPLE TIMES, ADDITIONAL EVENT DETAILS AND PATIENT DEMOGRAPHICS ARE UNAVAILABLE. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023835 ↗