LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575840VRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741135453), received between Feb 6, 2018 and Feb 25, 2025 — classified as 16 injuries, 1 malfunction.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Adverse 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 APPROXIMATELY ONE YEAR TEN MONTHS AND TWENTY-ONE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT RELATIONSHIP TO DEVICE AND PROCEDURE DETAILS WERE NOT PROVIDED. REPORTEDLY, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION IN THE TARGET LESION ON LEFT UPPER ARM FOR PROLONGED BLEEDING. FURTHERMORE, A LUTONIX DRUG COATED BALLOON WAS USED IN RE-INTERVENTION ON THE TARGET LESION AND THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 21457686 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY TWO MONTHS AND TWENTY THREE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT DEVELOPED ADVERSE EVENT OF STENOSIS AT CANNULATION ZONE AND AT CEPHALIC TO SUBCLAVIAN VEIN CONFLUENCE WHICH REQUIRED REINTERVENTION. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT RELATIONSHIP WAS NOT RELATED TO DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. REPORTEDLY, SURGICAL REVISION WAS PERFORMED IN RE-INTERVENTION AND NEW ACCESS WAS CREATED. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 20731314 ↗
• InjurySep 7, 2022Adverse 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 APPROXIMATELY ONE MONTH AND TEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, PROLONGED BLEEDING DUE TO STENOSIS OF THE TARGET LESION OCCURRED AND WAS SUCCESSFULLY TREATED. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME WAS RECOVERED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 15370200 ↗
• MalfunctionOct 29, 2021Crack; Material Rupture; Crack; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE MID ARM VEIN NEAR THE SHOULDER, THE BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12718173 ↗
• InjuryDec 18, 2018Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT DEFLATE AFTER SUCCESSFULLY TREATING THE TARGET LESION IN THE CEPHALIC AV FISTULA. THE HEALTH CARE PROFESSIONAL (HCP) ATTEMPTED TO USE AN INFLATION DEVICE TO GET THE LUTONIX BALLOON TO COLLAPSE ON ITSELF, SWITCHED TO A SYRINGE, BUT NEITHER OF THESE ATTEMPTS WERE SUCCESSFUL IN DEFLATING THE BALLOON. FINALLY, THE HCP REPORTEDLY ATTEMPTED TO RUPTURE THE BALLOON, BUT IN THE PROCESS THE AV FISTULA ALLEGEDLY RUPTURED. THE HCP REPAIRED THE RUPTURED AV FISTULA WITH A COVERED STENT. ALTHOUGH REQUESTED, IT IS UNKNOWN HOW THE LUTONIX DCB WAS REMOVED FROM THE PATIENT. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO FURTHER ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 8177429 ↗
• InjuryNov 13, 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 AXILLARY VEIN. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE TARGET LESION REPORTEDLY HAD A THROMBOSIS DETECTED VIA THRILL DURING A DIALYSIS PROCEDURE. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED INVOLVING PLACEMENT OF A NEW PERMCATH PORT, WHICH THE HEATH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, PROCEDURE, AND 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: Thrombosis

  MAUDE report 8067184 ↗
• InjurySep 25, 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESIONS LOCATED IN THE SYNTHETIC GRAFT IN THE PATIENT'S LEFT FOREARM AV FISTULA. APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S AV FISTULA WAS THROMBOSED VIA DIAGNOSTIC ANGIOGRAPHY. THE HEALTH CARE PROFESSIONAL (HCP) CHOSE TO ABANDONED THE ACCESS CIRCUIT AND CREATE A NEW ACCESS. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE AV ACCESS CIRCUIT, BUT NOT RELATED TO THE 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 3006513822-2018-00206.

  Patient problems: Thrombosis

  MAUDE report 7906276 ↗
• InjuryMay 2, 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 AXILLARY VEIN. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE TARGET LESION 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, BUT DEFINITELY RELATED TO 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 7480374 ↗
• InjuryMay 2, 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 ANASTOMOTIC REGION OF THE AXILLARY VEIN IN THE LEFT ARM. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE TARGET LESION 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, BUT DEFINITELY RELATED TO 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 7480173 ↗
• InjuryApr 19, 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 CEPHALIC VEIN ARCH. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT CEPHALIC 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, BUT DEFINITELY RELATED TO 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 7445035 ↗
• InjuryApr 19, 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 CANNULATION ZONE OF THE LEFT BASILIC VEIN IN THE AV FISTULA. APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT¿S AV ACCESS CIRCUIT REPORTEDLY HAD A PSEUDOANEURYSM. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, BUT WAS DEFINITELY RELATED TO THE PROCEDURE AND TO 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: Pseudoaneurysm

  MAUDE report 7444964 ↗
• InjuryApr 16, 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 ANASTOMOTIC REGION OF THE RIGHT BRACHIAL VEIN. APPROXIMATELY 6 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 NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO 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 7431993 ↗
• InjuryApr 16, 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 ANASTOMOTIC REGION OF THE PTFE AV FISTULA IN THE LEFT UPPER ARM. APPROXIMATELY 4 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 NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO 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 7431992 ↗
• InjuryApr 12, 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 ANASTOMOTIC REGION OF THE BASILIC VEIN IN THE RIGHT UPPER ARM AV FISTULA. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY THROMBOSED. A REVASCULARIZATION WAS ATTEMPTED VIA SURGICAL REVISION, BUT THE HCP DEEMED IT WAS NOT SUCCESSFUL. THE PATIENT HAD A TEMPORARY CATHETER TUNNELED AND IS CURRENTLY AWAITING A NEW VASCULAR ACCESS. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO 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: Thrombosis

  MAUDE report 7424684 ↗
• InjuryApr 12, 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 ANASTOMOTIC REGION OF THE CEPHALIC VEIN IN THE RIGHT UPPER ARM. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY THROMBOSED. A THROMBECTOMY WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO 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: Thrombosis

  MAUDE report 7424641 ↗
• InjuryMar 19, 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 REINTERVENTION PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE BASILIC VEIN OUTFLOW OF THE LEFT UPPER ARM AV FISTULA. APPROXIMATELY 3 MONTHS AFTER THE REINTERVENTION PROCEDURE, THE TARGET LESION 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, BUT POSSIBLY RELATED TO THE PROCEDURE AND DEFINITELY RELATED TO 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 7351333 ↗
• InjuryFeb 6, 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 AXILLARY VEIN IN THE AV FISTULA OF THE LEFT UPPER ARM. APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, THE PATIENT REPORTEDLY HAD A THROMBOSIS IN THE TARGET LESION. A THROMBECTOMY AND THROMBOLYSIS WERE PERFORMED AND THE HCP DEEMED IT UNSUCCESSFUL. THE HCP ABANDONED THE ACCESS SITE AND CREATED A NEW AV FISTULA WITH A GRAFT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO SUBSEQUENT ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: Thrombosis

  MAUDE report 7246759 ↗