LUTONIX® Drug Coated Balloon LX181307405FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741177712), received between Dec 14, 2020 and Aug 6, 2025 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Adverse 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 APPROXIMATELY FIVE MONTHS AND THIRTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF "STENOSIS SEGMENT BEYOND THE LEFT UPPER EXTREMITY FISTULA, SMALL PSEUDOANEURYSM IN THE AVF". REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. IT WAS FURTHER REPORTED THAT A STANDARD PTA AND LUTONIX DCB WAS USED DURING RE INTERVENTION IN THE TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 30%. THE RE INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS PROVIDED. IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ELEVEN MONTHS AND TWO DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF "THROMBOSED AVF". REPORTEDLY, ADVERSE EVENT WAS POSSIBLE RELATED TO THE DEVICE, DEFINITELY RELATED TO THE AV ACCESS CIRCUIT BUT NOT RELATED TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT A STANDARD PTA AND OTHER DCB WAS USED DURING RE-INTERVENTION IN THE TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOS

  Patient problems: Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 22729465 ↗
• MalfunctionDec 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE RIGHT ILIAC LESION, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002227 ↗
• MalfunctionDec 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE RIGHT ILIAC LESION, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002226 ↗