LUTONIX® Drug Coated Balloon LX3513051005FRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741123221), received between Jun 23, 2017 and Oct 16, 2019 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Adverse 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 LESIONS IN THE LEFT POPLITEAL ARTERY AND LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 24 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL AND SFA VASCULATURE WERE REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO REVASCULARIZATION WAS PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE LUTONIX DCB'S OR TO THE INDEX PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION: IT WAS FURTHER REPORTED THAT REVASCULARIZATION WAS PERFORMED ON THE TARGET LESION (MID 1/3 OF SFA).

  Patient problems: Reocclusion

  MAUDE report 9197779 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 22 DAYS POST INDEX PROCEDURE, CORE LAB ANALYSIS WAS PERFORMED AND IDENTIFIED REOCCLUSION OF THE TARGET LESION IN THE PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS FURTHER REPORTED THAT A REVASCULARIZATION, INVOLVING A VASCULAR BYPASS WAS PERFORMED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE OUTCOME WAS RESOLVED AND RECOVERED.

  Patient problems: Reocclusion

  MAUDE report 8754968 ↗
• InjuryMay 21, 2019Adverse 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, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT PROXIMAL POPLITEAL ARTERY. APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT POPLITEAL VASCULATURE WAS REPORTEDLY REOCCLUDED VIA ANGIOGRAM. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED INVOLVING ATHERECTOMY AND DCB ANGIOPLASTY. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE LUTONIX DCBS OR TO THE INDEX 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2019-00057 AND 3006513822-2019-00083.

  Patient problems: Reocclusion

  MAUDE report 8628392 ↗
• InjuryMay 21, 2019Adverse 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, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT PROXIMAL POPLITEAL ARTERY. APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT POPLITEAL VASCULATURE WAS REPORTEDLY REOCCLUDED VIA ANGIOGRAM. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED INVOLVING ATHERECTOMY AND DCB ANGIOPLASTY. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE LUTONIX DCBS OR TO THE INDEX 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2019-00057 AND 3006513822-2019-00084.

  Patient problems: Reocclusion

  MAUDE report 8628038 ↗
• InjuryFeb 28, 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 TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION INVOLVING PLACEMENT OF A BARE METAL STENT WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR 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 3006513822-2019-00029.

  Patient problems: Reocclusion

  MAUDE report 8380139 ↗
• InjuryNov 30, 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION IN RIGHT SFA WAS REPORTEDLY 90% REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION WAS PERFORMED INVOLVING A DCB AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND 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 8120367 ↗
• InjuryNov 7, 2017Adverse 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT PROXIMAL SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT UNDERWENT A REINTERVENTION OF THE TARGET LESION ON (B)(6) 2017. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7005677 ↗
• InjurySep 25, 2017Adverse 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VESSEL WAS REPORTEDLY 50-99% REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO REINTERVENTION WAS PERFORMED AT THAT TIME. APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS OF CLAUDICATION AND DUS IMAGING AT THIS TIME INDICATED THE TARGET LESION WAS STILL 50-99% OCCLUDED. NO ADDITIONAL INTERVENTION WAS PERFORMED AT THAT TIME. SUBSEQUENTLY, THE PATIENT UNDERWENT A REINTERVENTION OF THE TARGET LESION ON (B)(6) 2017. THE INVESTIGATOR ASSESSED THE OCCURRENCE OF REOCCLUSION WITH CLAUDICATION AND DETERMINED THE REOCCLUSION EVENTS WERE NEITHER DEVICE OR PROCEDURE RELATED, BUT RATHER PROGRESSION OF THE DISEASE. THE INVESTIGATOR ALSO ASSESSED THE PATIENT'S SYMPTOMS OF CLAUDICATION ARE SECONDARY TO THE TARGET LESION REOCCLUSION. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE

  Patient problems: Claudication; Reocclusion

  MAUDE report 6890228 ↗
• MalfunctionJun 23, 2017Material Rupture; Material Rupture

  IT WAS REPORTED TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS ALLEGEDLY RUPTURED LONGITUDINALLY BEFORE REACHING NOMINAL PRESSURE WHILE TREATING THE SAME TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO TREAT A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP PREDILATED THE CALCIFIED TARGET LESION WITH A 4MM NON-DCB BALLOON. THE HCP ATTEMPTED TO INFLATE THE FIRST LUTONIX DCB TO TREAT THE CALCIFIED TARGET LESION, BUT IT RUPTURED BEFORE REACHING NOMINAL PRESSURE. THE HCP THEN TOOK ANOTHER LUTONIX DCB, WITHOUT ANY ADDITIONAL PREDILATION OF THE TARGET LESION, AND ADVANCED IT TO THE TARGET LESION. THE HCP ATTEMPTED TO INFLATE THE SECOND LUTONIX DCB TO TREAT THE CALCIFIED TARGET LESION, BUT IT ALSO RUPTURED PRIOR TO REACHING NOMINAL PRESSURE. BOTH BALLOONS WERE REMOVED WITHOUT DIFFICULTLY. IN THE HCP OPINION, THE PATIENT'S ANATOMY AND CALCIFIC NATURE OF THE LESION POSSIBLY CAUSED THE BOTH MATERIAL RUPTURE ON EACH LUTONIX DCB. THE LUTONIX DCB'S WERE RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664808 ↗