Lutonix® Drug Coated Balloon LX351006100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741088407), received between Nov 17, 2016 and Mar 29, 2018 — 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.

• InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE CEPHALIC VEIN IN THE CANNULATION ZONE OF THE RIGHT UPPER ARM. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, THE PATIENT¿S RIGHT CEPHALIC VEIN WAS REPORTEDLY REOCCLUDED WITH A THROMBOSIS. A REVASCULARIZATION VIA VENOPLASTY WAS PERFORMED AND IT WAS NOT SUCCESSFUL. THE HCP DECIDED TO PUT A TUNNELED LINE IN BECAUSE THE PATIENT WAS UNABLE TO TOLERATE THE REVASCULARIZATION ATTEMPT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00072.

  Patient problems: Reocclusion; Thrombosis

  MAUDE report 7382759 ↗
• InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 19 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT MID-DISTAL SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS UNLIKELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2016-00206.

  Patient problems: Reocclusion

  MAUDE report 6110813 ↗