LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575680VRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741135408), received between Feb 2, 2021 and May 9, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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.

• InjuryMay 9, 2024Adverse 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 ONE MONTH POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF RECURRENT STENOSIS IN THE DRAINAGE VEIN AND JUXTA-ANASTOMOSIS REGION AND REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE UPPER ARM WITH FIFTY FOUR PERCENT INITIAL STENOSIS AND ZERO PERCENT FINAL RESIDUAL STENOSIS. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 19275999 ↗
• InjuryOct 9, 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 TWO MONTHS AND EIGHT DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF ANASTOMOTIC STENOSIS ON THE CEPHALIC VEIN DUE TO DECREASED ACCESS BLOOD FLOW WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY AND DRUG COATED BALLOON CATHETER PROCEDURES WERE PERFORMED TO TREAT DECREASED ACCESS BLOOD FLOW. THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. IT WAS FURTHER REPORTED THAT FIVE MONTHS AND TWENTY-TWO DAYS POST AN INDEX PROCEDURE COMPLETION, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF TWO STENOSIS ONE IN THE CEPHALIC VEIN AND THE OTHER ON THE SUBCLAVIAN VEIN DUE TO DECREASED ACCESS BLOOD FLOW WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY AND DRUG COATED BALLOON CATHETER PROCEDURES WERE PERFORMED TO TREAT DECREASED ACCESS BLOOD FLOW. THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW AC

  Patient problems: Restenosis

  MAUDE report 17894225 ↗
• MalfunctionFeb 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA CEPHALIC VEIN FOR TREATING STENOSIS AND HIGH VENOUS PRESSURE, THE BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RETRIEVED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556386 ↗
• MalfunctionFeb 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE RIGHT UPPER ARM, THE DRUG COATED DEVICE ALLEGEDLY RUPTURED AT 12 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264466 ↗