LUTONIX® Drug Coated Balloon LX3575780VRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741187698), received between May 21, 2021 and Sep 8, 2025 — classified as 3 injuries, 1 malfunction.

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

• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE STUDY (AV PAS) THAT SOMETIME LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DILATION CATHETER ON THE CEPHALIC VEIN OF THE LEFT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT HAD STENOSIS ON THE TARGET VEIN. THE EVENT WAS NOT RELATED TO THE SUBJECT DEVICE OR PROCEDURE.

  Patient problems: Restenosis; Stenosis

  MAUDE report 22990261 ↗
• InjuryMay 16, 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 TWENTY FOUR DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF CEPHALIC VEIN STENOSIS AND AV ACCESS CIRCUIT RE-INTERVENTION. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. A STANDARD PTA WAS USED IN RE-INTERVENTION ON TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 20%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS CREATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 22033296 ↗
• InjuryNov 12, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VESSEL, THE DRUG COATED BALLOON WAS ALLEGEDLY RUPTURED AT 6ATM. IT WAS FURTHER REPORTED THAT CATHETER HAD COMPLETELY BROKEN OFF AND WAS LOST INSIDE THE PATIENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12801697 ↗
• MalfunctionMay 21, 2021Difficult to Insert; Material Separation; Device-Device Incompatibility; Difficult to Insert; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE UPPER ARM FISTULA TO TREAT STENOSIS THROUGH AN ANTEGRADE APPROACH, THE DEVICE ALLEGEDLY FAILED TO ADVANCE OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DIFFICULT TO INSERT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861555 ↗