Lutonix® Drug Coated Balloon LX35130440Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741088544), received between Mar 17, 2016 and May 15, 2019 — classified as 10 injuries, 1 malfunction.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 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 AN INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT A LESION LOCATED IN THE RIGHT POPLITEAL ARTERY. APPROXIMATELY 37 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S POPLITEAL VASCULATURE 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. 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 8613583 ↗
• InjuryJun 1, 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 POPLITEAL ARTERY. APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT POPLITEAL VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED, APPROXIMATELY 17 MONTHS AFTER THE INDEX PROCEDURE, 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 FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7560372 ↗
• InjuryMay 22, 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 A REVASCULARIZATION PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE REVASCULARIZATION PROCEDURE, THE PATIENT¿S LEFT MID SFA 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 7533519 ↗
• InjuryApr 8, 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 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. 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 FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7405991 ↗
• InjuryOct 27, 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. ON (B)(6) 2016, APPROXIMATELY TWO MONTHS AFTER THE INITIAL REINTERVENTION, AN ADDITIONAL INTERVENTION WAS COMPLETED. THE 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00232.

  Patient problems: Reocclusion

  MAUDE report 6984437 ↗
• InjuryOct 24, 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 MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT MID 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 6974730 ↗
• InjuryMay 10, 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 MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT MID SFA 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 6559497 ↗
• MalfunctionApr 13, 2017Difficult to Remove; Device-Device Incompatibility; Torn Material; Difficult to Remove; Device-Device Incompatibility; Torn Material

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO REMOVE FROM THE GUIDEWIRE. THE HEALTH CARE PROFESSIONAL (HCP) USED AN 035 GUIDEWIRE TO GAIN ACCESS TO THE TARGET LESION. THE HCP SUCCESSFULLY LOADED THE CATHETER ONTO THE GUIDEWIRE AND MANEUVERED IT TO THE TARGET LESION. REPORTEDLY, THE HCP INFLATED THE BALLOON TO PERFORM A SUCCESSFUL TREATMENT. ALLEGEDLY, THE HCP HAD DIFFICULTY PULLING THE CATHETER OUT OF THE PATIENT AS IT WAS STUCK ON THE GUIDEWIRE. THE OUTER SHAFT OF THE CATHETER REPORTEDLY SEPARATED FROM THE INNER SHAFT OF THE CATHETER. ALTHOUGH REQUESTED, FURTHER EVENT DETAILS HAVE NOT BEEN OBTAINED FROM THE USER FACILITY. THE LUTONIX DCB HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6491002 ↗
• InjuryMar 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 18 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA 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, DRUG OR 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 ARE ASSOCIATED MANUFACTURERS REPORT NUMBER 3006513822-2016-00043.

  Patient problems: Reocclusion

  MAUDE report 5508149 ↗
• InjuryMar 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WERE 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 VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WITH AMPUTATION OF UNKNOWN EXTREMITY WERE PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, DRUG OR 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 ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00040.

  Patient problems: Reocclusion

  MAUDE report 5507863 ↗
• InjuryMar 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WITH AMPUTATION OF UNKNOWN EXTREMITY WERE PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, DRUG OR 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 ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00038.

  Patient problems: Reocclusion

  MAUDE report 5507784 ↗