LUTONIX® Drug Coated Balloon LX351306605FRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741123269), received between Nov 11, 2016 and Nov 29, 2023 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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.

• InjuryNov 29, 2023Adverse 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 THAT ELEVEN MONTHS AND EIGHT DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE AXILLARY VEIN VIA THE RIGHT UPPER ARM ACCESS, THE SUBJECT REPORTEDLY EXPIRED, AND THE PRIMARY CAUSE OF DEATH WAS UNKNOWN AT THIS TIME. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES AND NO ADVERSE EVENTS WERE REPORTED, AND THE RELATIONSHIP OF THE DEATH WITH THE DEVICE, PROCEDURE AND ARTERIOVENOUS ACCESS CIRCUIT IS UNKNOWN.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 18226134 ↗
• 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 12 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 8902282 ↗
• InjuryJul 31, 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. IT WAS FURTHER REPORTED THAT APPROXIMATELY 10 MONTHS POST 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 8846426 ↗
• 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED. 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 8148400 ↗
• InjuryApr 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 RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT MID SFA VESSEL WAS REPORTEDLY REOCCLUDED. APPROXIMATELY 1 MONTH LATER, 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 NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7406633 ↗
• InjuryAug 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 EXPERIENCED CLAUDICATION AND THE PATIENT¿S RIGHT MID SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. INVESTIGATOR ASSESSED 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 ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Claudication; Reocclusion

  MAUDE report 6818048 ↗
• MalfunctionMar 6, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED CIRCUMFERENTIALLY WHEN TREATING THE TARGET LESION AT APPROXIMATELY 12 ATMOSPHERES. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH THROUGH A 6 FRENCH TERUMO DESTINATION INTRODUCER SHEATH OVER AN ADVANTAGE GUIDEWIRE TO GAIN ACCESS TO THE MILDLY CALCIFIED TARGET LESION. THE HCP PREDILATED THE TARGET LESION WITH A MUSTANG BALLOON. THE MORPHOLOGY OF THE VESSEL PATHWAY WAS UNKNOWN, BUT NO PREVIOUSLY PLACED STENTS WERE PRESENT. THE HCP USED NEGATIVE PRESSURE DURING ADVANCEMENT OF THE CATHETER TO THE TARGET LESION. ALLEGEDLY, AFTER THE BALLOON RUPTURED, THE HCP REPORTEDLY WAS ABLE TO RETRIEVE ALL BALLOON FRAGMENTS FROM THE PATIENT. AFTER THE LUTONIX DCB CATHETER AND BALLOON FRAGMENTS WERE ALLEGEDLY REMOVED, ANOTHER DEVICE WAS REPORTEDLY USED TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS RETURNED FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6381500 ↗
• InjuryFeb 15, 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 LESIONS LOCATED IN THE RIGHT PROXIMAL-MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VESSEL 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 DEVICES OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00034.

  Patient problems: Reocclusion

  MAUDE report 6333133 ↗
• MalfunctionNov 11, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT FOUR ATMOSPHERES (ATMS) DURING THE TREATMENT OF THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP PREPARED THE LUTONIX DCB IN THE NORMAL FASHION AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES. IT IS UNKNOWN IF THE PATHWAY TO THE TARGET LESION OR THE LESION ITSELF WAS CALCIFIED OR TORTUOUS. THE HCP USED ANOTHER BALLOON TO TREAT THE TARGET LESION SUCCESSFULLY. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6095518 ↗