LUTONIX® Drug Coated Balloon LX3575740Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741088018), received between Mar 18, 2016 and Mar 18, 2016 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE, THE PHYSICIAN USED ONE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER TO TREAT THE TARGET LESION LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) OF THE LEFT LEG. APPROXIMATELY 3 MONTHS LATER, THE HCP TREATED THE PATIENT WITH THROMBECTOMY AND A PTA BALLOON. NEXT, THE HCP PLACED A STENT WITHIN THE ORIGINAL TARGET LESION RESULTING IN RESIDUAL STENOSIS OF 20%. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 5512042 ↗