LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575660VRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741135392), received between Nov 22, 2017 and Dec 15, 2025 — classified as 1 death, 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 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 (CL003301) THAT APPROXIMATELY TEN MONTHS AND EIGHTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF ¿ACCESS THROMBOSIS¿. REPORTEDLY, THE ADVERSE EVENT WAS POSSIBLY RELATED TO DEVICE, NOT RELATED TO THE PROCEDURE AND RELATED TO THE AV ACCESS CIRCUIT. IT WAS FURTHER REPORTED THAT A SURGICAL REVISION AND THROMBECTOMY/THROMBOLYSIS PROCEDURE AND LUTONIX DCB WAS USED DURING RE-INTERVENTION IN THE TARGET LESION IN THE AXILLARY VEIN WITH INITIAL STENOSIS OF 90% AND FINAL RESIDUAL STENOSIS OF 30% AND THROMBOSIS ON THE BASILIC VEIN WAS IDENTIFIED WITH INITIAL STENOSIS% AS 100% AND FINAL RESIDUAL STENOSIS % WAS 30%. THE RE-INTERVENTION WAS SUCCESSFUL, AND NO NEW ACCESS WAS PROVIDED.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 23801041 ↗
• InjuryJul 7, 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 (B)(4) THAT APPROXIMATELY TWO WEEKS AND THREE DAYS POST INDEX PROCEDURE USING A COMMERCIALLY AVAILABLE LUTONIX DRUG-COATED BALLOON CATHETER IN THE LEFT UPPER ARM ON THE BRACHIAL ARTERY ANASTOMOTIC LOCATION, THE SUBJECT HAD AN ADVERSE EVENT OF LEFT ARM AVF REVISION WITH SUPERFICIALIZATION AND BRANCH LIGATION DUE TO MATURED FISTULA TOO DEEP WITH SEVERAL BRANCHES. IT WAS FURTHER REPORTED THAT APPROXIMATELY ONE YEAR TWENTY-TWO DAYS POST INDEX PROCEDURE, THE SUBJECT HAD ANOTHER ADVERSE EVENT OF INDEX ARM ABANDONED AND RIGHT BRACHIOCEPHALIC AVF CREATION. REPORTEDLY, THE INDEX ARM LEFT UPPER EXTREMITY BRACHIOCEPHALIC AVF OCCLUDED DESPITE VENOPLASTY. THE ADVERSE EVENT RELATIONSHIP TO STUDY DEVICE AND STUDY PROCEDURE WERE NOT PROVIDED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22410571 ↗
• InjuryJan 28, 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 FIVE MONTHS AND NINE DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF RE-INTERVENTION DUE TO POOR FISTULA FLOW. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND PROCEDURE BUT POSSIBLY RELATED TO ARTERIOVENOUS ACCESS CIRCUIT. REPORTEDLY, THE SUBJECT UNDERWENT ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION IN THE TARGET LESION ON THE LEFT UPPER ARM FOR DECREASED ACCESS BLOOD FLOW. FURTHERMORE, A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED TO TREAT THE TARGET LESION RESTENOSIS WITH INITIAL STENOSIS OF NINETY-FIVE PERCENT AND FINAL RESIDUAL STENOSIS OF ZERO PERCENT. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL, AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 21261144 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT POST ANGIOPLASTY PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED LEFT AVF ANEURYSM. IT WAS FURTHER REPORTED THAT OPEN REPAIR OF SACCULAR LEFT CEPHALIC VEIN ANEURYSM WITH TRANSVERSE PRIMARY REPAIR VIA ANEURYSMORRHAPHY WAS PERFORMED FOR THE ADVERSE EVENT. CAUSAL RELATIONSHIP OF THE ADVERSE EVENT WITH PROCEDURE, DEVICE AND AV ACCESS CIRCUIT WAS NOT PROVIDED. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 20664500 ↗
• InjuryOct 3, 2024Adverse 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 THREE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF FEVER, PAIN AND SWELLING AT ANASTOMOSIS. IT WAS FURTHER REPORTED THAT A LARGE PSEUDOANEURYSM WAS NOTED ON ULTRASOUND. REPORTEDLY, THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE DEVICE BUT DEFINITELY RELATED TO THE PROCEDURE AND AV ACCESS CIRCUIT. REPORTEDLY, THE ADVERSE EVENT DOESN'T REQUIRE AV ACCESS CIRCUIT RE-INTERVENTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Fever; Pain; Pseudoaneurysm; Unspecified Infection

  MAUDE report 20357551 ↗
• InjurySep 23, 2024Adverse 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 ONE YEAR ONE MONTH AND SEVEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE BASILIC VEIN OUTFLOW, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING AND WAS TREATED WITH AN AV ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT RELATIONSHIP WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE DRUG COATED BALLOON CATHETER WERE USED TO TREAT THE TARGET LESION WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 9%. THE RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 20277814 ↗
• MalfunctionAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY FOUR DAYS POST AN ANGIOPLASTY PROCEDURE, THE PATIENT ALLEGEDLY RETURNED FOR REPEAT INTERVENTION IN LESS THAN THREE MONTHS. IT WAS REPORTED THAT THE RESULTS WERE SUBPAR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082740 ↗
• InjuryJul 30, 2024Adverse 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 ONE YEAR, SIX MONTHS, AND TWENTY-NINE DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN AT PERIANASTOMOTIC VENOUS LOCATION VIA THE LEFT FOREARM, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF UNABLE TO CANNULATE THE LEFT ARTERIOVENOUS FISTULA WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION CEPHALIC VEIN IN THE FOREARM HAD HUNDRED PERCENT INITIAL STENOSIS AND FIVE PERCENT FINAL RESIDUAL STENOSIS. FURTHERMORE, THE ACCESS THROMBOSIS IN THE FOREARM HAD HUNDRED PERCENT INITIAL STENOSIS AND FIVE PERCENT FINAL RESIDUAL STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, CATHETER-DIRECTED THROMBOLYSIS, AND BALLOON MACERATION WAS PERFORMED TO TREAT ACCESS THROMBOSIS AND CEPHALIC VEIN RESTENOSIS. TREATMENT REINTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES REPORTED FOR THIS SUBJECT TO DATE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 19869051 ↗
• MalfunctionDec 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON WAS ALLEGEDLY DIFFICULT TO BE DEFLATED. IT WAS FURTHER REPORTED THAT AFTER SEVERAL MINUTES AND ATTEMPTS, PHYSICIAN FINALLY GOT THE BALLOON OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417496 ↗
• InjurySep 1, 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 SIX MONTHS AND THIRTY DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN CEPHALIC VEIN, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF STENOSIS IN PERIANASTOMOTIC RADIAL CEPHALIC FISTULA WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION IN THE LEFT FOREARM HAD SEVENTY PERCENT INITIAL STENOSIS AND FIVE PERCENT FINAL RESIDUAL STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINOUS ANGIOPLASTY PROCEDURE AND LUTONIX DRUG COATED BALLOON CATHETER WERE USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RECOVERED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 17669406 ↗
• DeathNov 15, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE MONTH AND NINE DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, PATIENT HAD AN ADVERSE EVENT OF TARGET LESION RESTENOSIS. IT WAS FURTHER REPORTED THAT RE-INTERVENTION WAS PERFORMED AND RESTENOSIS WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Insufficient Information; Restenosis

  MAUDE report 15795995 ↗
• InjuryJul 12, 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 EIGHT MONTHS TWENTY DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, PATIENT HAD AN ADVERSE EVENT OF TARGET LESION RESTENOSIS AND FISTULA. IT WAS FURTHER REPORTED THAT RE-INTERVENTION WAS PERFORMED AND RESTENOSIS WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Restenosis; Unspecified Tissue Injury

  MAUDE report 14983815 ↗
• InjuryJun 13, 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 SIX MONTHS AND EIGHTEEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, RESTENOSIS OF THE TARGET LESION OCCURRED AND WAS SUCCESSFULLY TREATED. THE RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 14673111 ↗
• InjuryFeb 22, 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 SIX MONTHS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, RESTENOSIS OF THE TARGET LESION OCCURRED AND WAS SUCCESSFULLY TREATED WITH STANDARD PTA. THE RE-INTERVENTION WAS SUCCESSFUL AND THE PATIENT RECOVERED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Fistula; Restenosis; Unspecified Tissue Injury

  MAUDE report 13577226 ↗
• MalfunctionApr 16, 2021Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Packaging Problem; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE PACKAGE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY UNSTERILE . THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676700 ↗
• InjuryJun 4, 2020Adverse 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 DRUG COATED BALLOON (DCB) CATHETER WAS USED TO TREAT TARGET LIMB AND THE PATIENT EXPERIENCED SHORTNESS OF BREATH. THE OUTCOME OF THE EVENT WAS RESOLVED AND THE PATIENT HAS RECOVERED. THE PHYSICIAN STATES THAT THE RELATIONSHIP TO THE DEVICE WAS POSSIBLY RELATED AND THE RELATIONSHIP TO THE PROCEDURE WAS ALSO POSSIBLY RELATED.

  Patient problems: Chest Pain; Dyspnea; Stenosis

  MAUDE report 10119771 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON COMPLETION OF AN ANGIOPLASTY PROCEDURE IN A FOREARM FISTULA, THE PATIENT ALLEGEDLY DEVELOPED AN ANAPHYLACTIC REACTION. THE HEALTH CARE PROVIDED REPORTEDLY BELIEVES THAT PACLITAXEL IS ONE OF THE "MOST LIKELY" CAUSES OF THE POSSIBLE ANAPHYLACTIC REACTION. THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT, WHERE THE REACTION WAS RESOLVED OVERNIGHT. THE PATIENT WAS REPORTEDLY STABLE AFTER THE REACTION WAS RESOLVED.

  Patient problems: Anaphylactic Shock

  MAUDE report 8933075 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ALLEGEDLY, THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA WHILE THE TARGET LESION WAS BEING TREATED WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH WITH A 6 FRENCH INTRODUCER SHEATH TO ACCESS THE PATIENT'S TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP PLACED A FILTER, OF UNKNOWN TYPE, BELOW THE TREATMENT LOCATION AND PROCEEDED TO USE A MEDTRONIC SILVER HAWK OR HAWK ONE DEVICE TO DEBULK THE SFA. AFTER THE ATHERECTOMY, A STANDARD COOK BALLOON WAS USED TO PRE-DILATE THE TARGET LESION. REPORTEDLY, THE LUTONIX DCB WAS INFLATED AND HELD AT NOMINAL PRESSURE FOR TWO MINUTES. ALLEGEDLY, DURING THE TWO MINUTE INFLATION PERIOD, THE PATIENT¿S BLOOD PRESSURE REPORTEDLY DROPPED BY APPROXIMATELY 30 MILLIMETER OF MERCURY. ALLEGEDLY, THE PATIENT WENT INTO BRADYCARDIA, OF WHICH THE RATE IS UNKNOWN. THE PATIENT'S HEART RATE AND BLOOD PRESSURE WERE REPORTEDLY NORMAL PRIOR TO THE LUTONIX DCB INFLATION. THE EPISODE OF BRADYCARDIA WAS REPORTEDLY "BRIEF, APPROXIMATELY FIVE MINUTES". THE HCP DEFLATED THE LUTONIX DCB, WHICH RESULTED IN THE PATIENT'S HEA

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 7571332 ↗
• InjuryNov 22, 2017Deflation Problem; Retraction Problem; Torn Material; Deflation Problem; Retraction Problem; Torn Material

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO DEFLATE AFTER TREATMENT OF THE SUBCLAVIAN ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) PREDILATED THE TARGET LESION PRIOR TO DCB TREATMENT. UPON REMOVAL OF THE LUTONIX DCB THROUGH THE INTRODUCER SHEATH, ALLEGEDLY THE BALLOON PORTION OF THE DEVICE DETACHED FROM THE CATHETER SHAFT. IT IS UNCLEAR AT THIS TIME IF THE BALLOON COMPLETELY DETACHED FROM THE CATHETER OR IF A BALLOON BOND SEPARATED FROM THE CATHETER SHAFT. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION, BUT AT THIS TIME THE FACILITY WILL NOT RELEASE THE SAMPLE TO THE MANUFACTURER. ALTHOUGH REQUESTED, THE PHYSICAL SAMPLE, PATIENT DEMOGRAPHICS, AND ADDITIONAL EVENT DETAILS WERE NOT AVAILABLE. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7054589 ↗