Lutonix® Drug Coated Balloon LX3575640Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741088001), received between Feb 6, 2018 and Feb 9, 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.

• InjuryFeb 9, 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 JUXTA-ANASTOMOTIC OF THE AXILLARY VEIN IN THE AV FISTULA OF THE RIGHT UPPER ARM. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT REPORTEDLY HAD A THROMBUS WITHIN THE TARGET LESION. THE HCP PERFORMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A SURGICAL REVISION TO EXPLORE THE VENOUS ANASTOMOSIS. A THROMBECTOMY INVOLVING THROMBOLYSIS THERAPY WAS PERFORMED, BUT THE HCP DEEMED THIS TREATMENT TO BE UNSUCCESSFUL. REPORTEDLY, RESIDUAL THROMBI WITH PSEUDOANEURYSM WERE PRESENT AFTER THE UNSUCCESSFUL PROCEDURE. THE INVESTIGATOR ASSESSED THAT THE EVENT, THROMBOSIS, 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 SUBSEQUENT ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: Pseudoaneurysm; Thrombosis

  MAUDE report 7261317 ↗
• InjuryFeb 6, 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 LEFT CEPHALIC VEIN ARCH. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT CEPHALIC VESSEL WAS REPORTEDLY REOCCLUDED, WHICH DECREASED THE BLOOD FLOW TO THE AV FISTULA. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7246757 ↗