Lutonix® Drug Coated Balloon LX35100440Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741088261), received between Oct 27, 2015 and Oct 27, 2015 — 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.

• InjuryOct 27, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE THE PHYSICIAN USED TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS TO TREAT THE TARGET LESION LOCATED FROM THE MIDDLE ONE-THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL ARTERY OF THE RIGHT LEG. APPROXIMATELY 8 MONTHS LATER, THE HCP WAS UNABLE TO OBTAIN PATIENT ACCESS TO THE REOCCLUDED RIGHT SFA THROUGH THE COMMON FEMORAL ARTERY DUE TO THE HIGH DEGREE OF CALCIFICATION. THEREFORE, A PERIPHERAL VASCULAR BYPASS SURGERY WAS PERFORMED FROM THE COMMON FEMORAL TO THE POPLITEAL ARTERY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2015-00046.

  Patient problems: Reocclusion

  MAUDE report 5181497 ↗