LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751040VRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741135514), received between May 2, 2018 and Jul 30, 2025 — classified as 1 death, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Adverse 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 (AV PAS) THAT SOMETIME LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DILATION CATHETER ON THE BASILIC VEIN OF THE LEFT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT HAD STENOSIS ON THE TARGET VEIN. IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN ADVERSE EVENT OF ENCEPHALOPATHY. THE RELATIONSHIP OF THE EVENT WITH THE DEVICE, PROCEDURE, OR AV ACCESS CIRCUIT INTERVENTION WAS NOT REPORTED. THE EVENT DID NOT RESULT IN A RE-INTERVENTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Encephalopathy; Restenosis; Stenosis

  MAUDE report 22661990 ↗
• 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 TWO MONTHS AND TWENTY THREE DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT ALLEGEDLY 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 20731442 ↗
• InjurySep 16, 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 THREE MONTHS AND SIX DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN AT OUTFLOW NEAR CANNULATION ZONE VIA THE LEFT UPPER ARM, THE SUBJECT HAD AN ADVERSE EVENT OF STENOSIS OF OUTFLOW NEAR CANNULATION ZONE IN BASILIC VEIN OF ARTERIOVENOUS FISTULA. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE UPPER ARM WITH FIFTY PERCENT INITIAL STENOSIS AND TWENTY PERCENT FINAL RESIDUAL STENOSIS. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT BASILIC VEIN RESTENOSIS. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 20226876 ↗
• InjuryNov 27, 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 APPROXIMATELY THREE MONTHS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE CEPHALIC VEIN ARCH, THE SUBJECT HAD AN ADVERSE EVENT OF STENOSIS AT CEPHALIC ARCH IN THE ARTERIOVENOUS FISTULA AND WAS SUCCESSFULLY TREATED WITH AN AV ACCESS CIRCUIT REINTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND TWO DRUG COATED BALLOON CATHETERS WERE USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED. IT WAS FURTHER REPORTED THAT SIX MONTHS AND ELEVEN DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF STENOSIS AT CEPHALIC ARCH IN THE ARTERIOVENOUS FISTULA AND WAS SUCCESSFULLY TREATED WITH AN AV ACCESS CIRCUIT REINTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME WAS RESOLVED.

  Patient problems: Restenosis

  MAUDE report 18208362 ↗
• InjuryJun 26, 2023Adverse 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 THREE WEEKS AND FOUR DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT DEVELOPED ADVERSE EVENT ELEVATED VENOUS PRESSURE IN ARTERIOVENOUS FISTULA, A STENOSIS IN MID CEPHALIC AND CEPHALIC WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. IT WAS FURTHER REPORTED THAT TWO MONTHS AND TWENTY-TWO DAYS POST INDEX PROCEDURE, THE SUBJECT HAD ADVERSE EVENT STENOSIS IN MID CEPHALIC FISTULA DUE TO DECREASED ACCESS BLOOD FLOW AND ELEVATED VENOUS PRESSURES WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. FURTHERMORE, THE SUBJECT HAD TARGET LESION RESTENOSIS IN CEPHALIC VEIN WITH MAXIMUM INITIAL STENOSIS OF FIFTY PERCENT. REPORTEDLY, BOTH THE ADVERSE EVENTS WERE NOT RELATED TO DEVICE, POSSIBLY RELATED TO PROCEDURE, AND DEFINITELY RELATED TO AV ACCESS CIRCUIT. STANDARD PERCUTANEOUS TRANSLUMINOUS ANGIOPLASTY WAS USED FOR TREATMENT. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF ZERO PERCENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension; Restenosis

  MAUDE report 17198794 ↗
• DeathSep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN PREPARATION FOR A 12 MONTH FOLLOW UP VISIT FOR A CLINICAL TRIAL, THE PATIENT¿S CHART HAD INDICATED THE PATIENT HAD EXPIRED. THE PATIENT HAD UNDERGONE AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE LEFT UPPER ARM IN THE CEPHALIC VEIN AT THE OUTFLOW APPROXIMATELY SEVEN MONTHS AND EIGHT DAYS BEFORE EXPIRATION. NO INFORMATION IN CHART WAS PROVIDED REGARDING THE PATIENT¿S CAUSE OF DEATH. THE RELATIONSHIP OF THE ADVERSE EVENT WITH THE DEVICE, PROCEDURE AND AV ACCESS CIRCUIT ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15433712 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST ANGIOPLASTY PROCEDURE IN THE LEFT SUBCLAVIAN VEIN, THE PATIENT ALLEGEDLY EXPERIENCED RESTENOSIS. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 13480393 ↗
• MalfunctionMar 2, 2021Material Separation; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Material Separation; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO THE TREATMENT PROCEDURE THE CATHETER ALLEGEDLY NOT ALLOWED GUIDWIRE DUE TO THERE WAS A HARD PIECE OF PLASTIC FUSED AT THE END OF CATHETER TIP. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397417 ↗
• InjuryOct 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 SUBCLAVIAN VEIN OF THE LEFT UPPER ARM. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED, WHICH CAUSED THE PATIENT'S ARM AND HAND TO SWELL. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ONLY. THE HCP DEEMED THE PROCEDURE 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 7984810 ↗
• 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 3 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 7480298 ↗