LUTONIX® Drug Coated Balloon LX351305605FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741123207), received between Jun 23, 2017 and Aug 5, 2024 — classified as 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2024Restricted Flow rate; Adverse Event Without Identified Device or Use Problem; Restricted Flow rate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY FOUR MONTHS AND FOUR DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT DEVELOPED ADVERSE EVENT OF DECREASED FLOW DUE TO STENOSIS OF JUXTA-ANASTOMOTIC REGION WHICH REQUIRED REINTERVENTION. REPORTEDLY, THE ADVERSE EVENT WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND OTHER DRUG COATED BALLOON. FURTHERMORE, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE RE-INTERVENTION INVOLVED ON THE TARGET LESION ON THE CEPHALIC VEIN WITH INITIAL STENOSIS OF 51.1% AND FINAL RESIDUAL STENOSIS OF 20%. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 19905229 ↗
• MalfunctionApr 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH LEFT SUPERFICIAL FEMORAL ARTERY, THE DRUG COATED PTA BALLOON ALLEGEDLY RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625922 ↗
• 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, 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 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION WAS NOT PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES AND 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 3006513822-2019-00044.

  Patient problems: Reocclusion

  MAUDE report 8408584 ↗
• InjuryFeb 13, 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED BASED ON THE HEALTH CARE PROFESSIONALS (HCP) OPINION THAT THE PATIENT'S RIGHT LEG RUTHERFORD CLASS IS LEVEL I AND CURRENTLY NO CLINICAL SYMPTOMS ARE PRESENT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND 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 8335621 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE (B)(6) CLINICAL REGISTRY, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED AS THE PRIMARY TREATMENT FOR AN OCCLUDED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) PREDILATED THE TARGET LESION WITH AN ULTRASCORE BALLOON SUCCESSFULLY. THE HCP PERFORMED IMAGING AND THE VESSEL WAS CLEAR OF ALL OBSTRUCTIONS. THE HCP USED TWO LUTONIX DCB'S TO TREAT THE TARGET LESION LOCATION SUCCESSFULLY. REPORTEDLY, THE HCP PERFORMED IMAGING AFTER DCB TREATMENT AND THE VESSEL WAS OBSTRUCTED DUE TO A GRADE C DISSECTION. THE HCP USED A STENT TO CORRECT THE OBSTRUCTED FLOW IN THE TREATED VESSEL. THE LUTONIX DCBS WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00264.

  Patient problems: Intimal Dissection

  MAUDE report 8069811 ↗
• InjuryFeb 20, 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 JUXTA-ANASTOMOTIC OF THE CEPHALIC VEIN IN THE LEFT FOREARM. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION IN THE JUXTA-ANASTOMOTIC OF THE LEFT CEPHALIC VEIN WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, AND DEFINITELY RELATED TO THE PROCEDURE AND THE AV ACCESS CIRCUIT. 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 7282170 ↗
• MalfunctionOct 10, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED PRIOR TO INFLATION. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH THROUGH THE RIGHT COMMON FEMORAL ARTERY TO TREAT THE TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP PREDILATED THE TARGET LESION PRIOR TO THE LUTONIX DCB TREATMENT. THE HCP ADVANCED THE LUTONIX DCB TO THE TARGET LESION, UNDER NEGATIVE PRESSURE. THE HCP REPORTED BLOOD INFILTRATING THE ENDOFLATOR PRIOR TO INFLATING THE LUTONIX DCB, WHICH THE HCP BELIEVED INDICATES A "HOLE" WAS PRESENT IN THE BALLOON. THE LUTONIX DCB WAS REMOVED INTACT AND ANOTHER LUTONIX DCB WAS USED TO COMPLETE THE PROCEDURE. ALTHOUGH REQUESTED, THE TARGET LESION AND VESSEL MORPHOLOGY ARE UNKNOWN. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6935128 ↗
• 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 6664408 ↗