LUTONIX® Drug Coated Balloon LX3513041505FRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741123184), received between Aug 2, 2018 and Apr 3, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON WAS ALLEGEDLY COULD NOT BE WITHDRAWN AND IT WAS WITHDRAWN TOGETHER WITH THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY WRINKLED. REPORTEDLY, THE PATIENT EXPERIENCED ENDOTHELIAL DETACHMENT AND OCCLUSION OF THE DORSALIS PEDIS ARTERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Endothelial Cell Loss

  MAUDE report 21759884 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE AND A HALF YEARS POST ANGIOPLASTY PROCEDURE, THE PATIENT¿S POPLITEAL ARTERY WAS ALLEGEDLY REOCCLUDED. IT WAS FURTHER REPORTED THAT A REVASCULARIZATION WAS PERFORMED USING AN ANOTHER DEVICE AFTER TWENTY MONTHS. THE PATIENT REPORTED TO BE STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13025085 ↗
• MalfunctionMar 9, 2020Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DRUG-COATED BALLOON ALLEGEDLY BECAME STUCK ON THE EDGE OF A STENT AND WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9809100 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 FEMORAL ARTERY. APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT FEMORAL ARTERY WAS REPORTEDLY REOCCLUDED, AND THE PATIENT EXPERIENCED THE LEFT LOWER LEG PAINS. A REVASCULARIZATION WAS NOT PERFORMED,BECAUSE OF ITS DIFFICULTY, BASED ON THE DECISION BY HEALTHCARE PROFESSIONAL (HCP), AND AN AMPUTATION PROCEDURE OF THE LEFT LEG ABOVE THE KNEE WAS PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 9189029 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 RIGHT POPLITEAL ARTERY AND FEMORAL ARTERY. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE TARGET LESION WAS REPORTEDLY REOCCLUDED, AND THE PATIENT EXPERIENCED THE RIGHT FIRST TOE PAINS. A REVASCULARIZATION WAS NOT PERFORMED, BECAUSE OF ITS DIFFICULTY, BASED ON THE DECISION BY HEALTH CARE PROFESSIONAL (HCP). AN AMPUTATION PROCEDURE OF THE RIGHT LEG ABOVE THE KNEE WAS PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 9187061 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 FEMORAL ARTERY. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT FEMORAL ARTERY WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 8902379 ↗
• MalfunctionMar 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS ALLEGEDLY UNABLE TO INFLATE BECAUSE IT WAS "BROKEN". THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS THROUGH AN IPSILATERAL APPROACH. REPORTEDLY, THE HCP PRE-DILATED THE 70% NARROWED, 10CM TARGET LESION IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 4MMX150MM BALLOON. THE PATIENT USED A TERUMO GLIDEWIRE TO DELIVER THE LUTONIX DCB TO THE TARGET LESION. REPORTEDLY, THERE WERE NO STENTS IN THE TREATMENT AREA OR TRACKING PATH. THE PHYSICIAN ATTEMPTED TO INFLATE THE LUTONIX DCB WITH A BD PRESTO INDEFLATOR, BUT WAS UNABLE TO. THE PHYSICIAN PROVIDED A VIDEO TO ILLUSTRATE WHAT OCCURRED DURING THE PROCEDURE. A REVIEW OF THE VIDEO NOTED THE DEVICE WAS LEAKING BODY FLUID CONTAMINATION FROM THE INFLATION HUB WHILE APPLYING NEGATIVE PRESSURE. IT ALSO REVEALED, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE DEVICE WAS LEAKING FROM THE END OF THE CATHETER WHILE BEING FLUSHED. THE LUTONIX DCB WAS REMOVED WITHOUT ISSUES AND ANOTHER LUTONIX DCB WAS USED TO COMPLETE THE PROCEDURE. THE SAMPLE WAS STERILIZED AND CLEANED BY THE USER FACILITY. THE SAMPLE HAS BEEN RETURNED FOR F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426872 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION INVOLVING PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR THE 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 8408241 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE CALCIFIED TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. THE HEALTH CARE PROFESSIONAL (HCP) CHOOSE NOT TO DO A REVASCULARIZATION BECAUSE NO CLINICAL SYMPTOMS WERE OBSERVED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES OR THE PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE 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 3006513822-2019-00002.

  Patient problems: Reocclusion

  MAUDE report 8222742 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 POPLITEAL ARTERY. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL ARTERY WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION HAS NOT BEEN PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, BUT NOT RELATED TO THE 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 8148401 ↗
• InjuryAug 27, 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED VIA PLAIN OLD BALLOON ANGIOPLASTY (POBA) AND A CUTTING/SCORING BALLOON CATHETER. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED THE REINTERVENTION SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY 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 7818627 ↗
• InjuryAug 2, 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 POPLITEAL ARTERY. APPROXIMATELY 15 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL ARTERY WAS REPORTEDLY REOCCLUDED. 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 7742356 ↗