LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX351001060VRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741135774), received between Jul 1, 2020 and Nov 24, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 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 EIGHT MONTHS AND TWO WEEKS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER FOR TARGET LESION STENOSIS ON THE LEFT UPPER ARM BASILIC VEIN, THE SUBJECT UNDERWENT ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM FOR AV FISTULA ANEURYSM AND PAIN WITHOUT STENOSIS. IT WAS FURTHER REPORTED THAT A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED IN THE RE-INTERVENTION ON THE TARGET LESION ON THE UPPER ARM BRACHIAL VEIN WITH INITIAL STENOSIS OF 0% AND FINAL RESIDUAL STENOSIS OF 0%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL. FURTHERMORE, THE SUBJECT UNDERWENT ANOTHER ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM FOR AV FISTULA ANEURYSM AND PAIN WITHOUT STENOSIS. A STANDARD PTA WAS USED IN THE RE-INTERVENTION ON THE TARGET LESION ON THE UPPER ARM BRACHIAL VEIN WITH INITIAL STENOSIS OF 0% AND FINAL RESIDUAL STENOSIS OF 0%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS CREATED.

  Patient problems: Aneurysm; Pain; Restenosis

  MAUDE report 23631971 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TREATMENT WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, POST INDEX PROCEDURE STENOSIS WAS ALLEGEDLY IDENTIFIED VIA IMAGING. IT WAS FURTHER REPORTED THAT THE MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Reocclusion

  MAUDE report 10221486 ↗