Lutonix® Drug Coated Balloon LX35130480Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741088629), received between Oct 30, 2015 and Oct 23, 2018 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

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 23, 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 MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 16 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION IN THE RIGHT MID SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A CLINICALLY DRIVEN 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. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION: IT WAS REPORTED THAT APPROXIMATELY 26 MONTHS POSY INDEX PROCEDURE, AN OCCLUSION OR RESTENOSIS WAS IDENTIFIED VIA IMAGING. IT WAS FURTHER REPORTED THAT APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE, AN OCCLUSION WAS IDENTIFIED VIA IMAGING. NO INTERVENTION WAS PERFORMED.

  Patient problems: Reocclusion

  MAUDE report 7995552 ↗
• InjuryMar 5, 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 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL VESSEL 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 7314168 ↗
• InjuryNov 1, 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 DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT DISTAL SFA VASCULATURE 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 6994933 ↗
• InjuryNov 1, 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, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA AND POPLITEAL VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON (B)(6) 2016 FOLLOWED BY A FEMORAL-POPLITEAL BYPASS ON (B)(6) 2016 OF THE TARGET LEG WITH A SAPHENOUS VEIN GRAFT. THE TARGET LESIONS ARE NO LONGER ABLE TO BE EVALUATED. 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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2017-00251 AND 3006513822-2017-00252.

  Patient problems: Reocclusion

  MAUDE report 6993398 ↗
• InjuryOct 26, 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE 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 6981498 ↗
• MalfunctionMar 17, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS UNABLE TO INFLATE DURING TREATMENT OF THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO TREAT THE RIGHT LOWER POPLITEAL ARTERY. THE PATHWAY AND THE LESION WERE NOT TORTUOUS OR CALCIFIC IN NATURE, THUS THE HCP WAS ABLE TO MANEUVER THE BALLOON TO THE TARGET LESION WITHOUT DIFFICULTY. WHILE INFLATING THE BALLOON, IT WOULD NOT INCREASE PRESSURE AND THE CONTRAST SOLUTION WAS LEAKING FROM THE BALLOON. THE HCP REMOVED THE BALLOON IN ITS ENTIRETY, WITHOUT DIFFICULTY. THE HCP DOES NOT BELIEVE THE ANATOMY OR THE TARGET LESION MORPHOLOGY CAUSED OR CONTRIBUTED TO THE CONTRAST LEAKING FROM THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6413556 ↗
• MalfunctionNov 19, 2015Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY FAILED TO INFLATE AT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) TREATMENT SITE. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS ON THE RIGHT SIDE AND PREDILATED THE TARGET LESION WITH A NORMAL PTA BALLOON SUCCESSFULLY. REPORTEDLY, THE LUTONIX DCB WAS ADVANCED TO THE SFA; HOWEVER, AS THE BALLOON WAS INCREMENTALLY INFLATED, THE BALLOON ALLEGEDLY WOULD NOT STAY INFLATED. THE DEVICE WAS SUCCESSFULLY REMOVED. ANOTHER LUTONIX DCB OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5237420 ↗
• MalfunctionNov 11, 2015Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT HOLD PRESSURE. THE HEALTH CARE PROFESSIONAL (HCP) INDICATED THE BALLOON WOULD NOT INFLATE. THE HCP RETRACTED THE LUTONIX DCB CATHETER THROUGH THE SHEATH WITHOUT DIFFICULTY. THE HCP USED ANOTHER LUTONIX DCB TO TREAT THE TARGET LESION SUCCESSFULLY. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5219167 ↗
• InjuryOct 30, 2015Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER SUCCESSFUL TREATMENT WITH THE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, VASCULAR ACCESS WAS ALLEGEDLY LOST. SPECIFICALLY, THE HEALTH CARE PROFESSIONAL (HCP) REMOVED THE GUIDE WIRE WHILE LEAVING THE USED LUTONIX DCB IN PLACE. REPORTEDLY, WHILE THE HCP ADVANCED A SECOND GUIDE WIRE, THE GUIDE WIRE BECAME STUCK WITHIN THE INNER LUMEN OF THE LUTONIX DCB. AFTER THE CATHETER WAS SUCCESSFULLY REMOVED, THE HCP NOTED THE GUIDE WIRE WAS ADJACENT TO THE INNER CATHETER, INSIDE THE BALLOON. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5191454 ↗