LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575540VRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741135347), received between Apr 20, 2021 and Aug 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT APPROXIMATELY SOMETIMES POST INDEX PROCEDURE USING A LUTONIX DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN FOR TARGET LESION STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF HEMATOMA AND STEAL SYNDROME. THE ADVERSE EVENT RELATIONSHIP TO THE DEVICE, PROCEDURE AND ARTERIOVENOUS ACCESS CIRCUIT WAS NOT REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Restenosis; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 22781642 ↗
• InjuryApr 20, 2021Adverse 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 ONE YEAR AND TWENTY-EIGHT DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED NONFUNCTIONING AV FISTULA DUE TO A FOCAL STENOSIS OF THE BRACHIOBASILLIC, AV ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED AND TREATED WITH STANDARD PTA. APPROXIMATELY ONE YEAR AND ONE MONTH POST INDEX PROCEDURE, THE SUBJECT DEVELOPED HIGH GRADE STENOSIS OF AV FISTULA AND AV ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11691596 ↗