LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575960VRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741135491), received between May 15, 2018 and Jul 2, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRUG COATED BALLOON ANGIOPLASTY (DCB) PROCEDURE USING THE LUTONIX DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 10 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383754 ↗
• InjuryFeb 20, 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, two months and twenty four days post an index procedure completion using a drug coated balloon catheter for cephalic vein stenosis, the subject had an adverse event of intermittent prolonged bleeding after dialysis. Reportedly, the adverse event was possibly related to study device and procedure but not related to AV access circuit. It was further reported that approximately six months and six days post an index procedure, the subject underwent AV access circuit re-intervention for prolonged bleeding. A standard percutaneous transluminal angioplasty was used in re-intervention for target lesion on cephalic vein with initial stenosis of 50 percent and final residual stenosis of 0 percent.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Restenosis

  MAUDE report 21419169 ↗
• InjurySep 9, 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 SOMETIME POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT DEVELOPED ADVERSE EVENT OF STENOSIS OF SUBCLAVIAN VEIN AND IN-STENT STENOSIS IN SUBCLAVIAN VEIN REQUIRING RE-INTERVENTION. REPORTEDLY, THE ADVERSE EVENT WAS TREATED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENT GRAFT. FURTHERMORE, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 20167591 ↗
• InjuryApr 26, 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 APPROXIMATELY THREE MONTHS AND NINETEEN DAYS POST ANGIOPLASTY PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF ANEURYSM FORMATION AND HIGH-FLOW ACCESS. THE ADVERSE EVENT WAS TREATED WITH NON-TARGET LESION CEPHALIC VEIN INFLOW WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE PATIENT RECOVERED. APPROXIMATELY NINE MONTHS AND THREE DAYS POST ANGIOPLASTY PROCEDURE, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF HYPERPULSATILE FISTULA AND ANEURYSM FORMATION. THE ADVERSE EVENT WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE PATIENT RECOVERED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Fistula

  MAUDE report 19192900 ↗
• InjuryMar 11, 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 AND TWENTY-TWO DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN AT SWING POINT, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF LEFT UPPER EXTREMITY SWELLING AND STENOSIS OF INDEX LESION DUE TO ARM SWELLING WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE UPPER ARM WITH SEVENTY PERCENT INITIAL STENOSIS AND TEN PERCENT FINAL RESIDUAL STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT ARM SWELLING. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES AND NO SECONDARY STAGE PROCEDURES WERE REPORTED FOR THIS SUBJECT TO DATE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis; Swelling/ Edema

  MAUDE report 18874451 ↗
• InjuryDec 30, 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 FIVE MONTHS AND NINETEEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE CEPHALIC VEIN OUTFLOW, THE SUBJECT HAD AN ADVERSE EVENT OF CEPHALIC VEIN RESTENOSIS AND WAS TREATED WITH AN AV ACCESS CIRCUIT REINTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND OTHER DRUG COATED BALLOON CATHETER WERE USED TO TREAT THE TARGET LESION. THE RE-INTERVENTION WAS SUCCESSFUL AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Aneurysm; Restenosis; Thrombosis/Thrombus

  MAUDE report 18422777 ↗
• InjuryNov 17, 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 EIGHTEEN DAYS POST INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN AT OUTFLOW NEAR CANNULATION ZONE, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF CEPHALIC VEIN STENOSIS WHICH REQUIRED ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. IT WAS FURTHER REPORTED THAT THE TARGET LESION IN THE CEPHALIC VEIN AT OUTFLOW NEAR CANNULATION ZONE HAD AN INITIAL STENOSIS OF NINETY PERCENT AND TEN PERCENT FINAL RESIDUAL STENOSIS. IT WAS ALSO REPORTED THAT STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY, STENT GRAFT PLACEMENT AND OTHER DRUG-COATED BALLOON ANGIOPLASTY WERE PERFORMED TO TREAT THE RESTENOSIS IN CEPHALIC VEIN. FURTHERMORE, THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, AND SO A NEW ACCESS WAS NOT CREATED. REPORTEDLY, THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Restenosis; Swelling/ Edema

  MAUDE report 18157400 ↗
• InjuryJul 3, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY WOULD NOT DEFLATE AT THE PROXIMAL END. IT WAS FURTHER REPORTED THAT THE PHYSICIAN INCREASED THE ATMOSPHERIC PRESSURE AND PURPOSELY RUPTURED THE BALLOON IN ORDER TO PULL IT BACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 17247921 ↗
• MalfunctionMar 31, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DIFFICULT TO REMOVE FROM THE SHEATH. REPORTEDLY THE PATIENT EXPERIENCE PROLONG BLEEDING IN ACCESS SITE; HOWEVER THERE IS NO INFORMATION REGARDING TREATMENT OR MEDICATION PROVIDED FOR BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657880 ↗
• InjurySep 6, 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 FIVE MONTHS AND EIGHTEEN DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, TARGET LESION RESTENOSIS AND ARTERIOVENOUS FISTULA THROMBOSIS OCCURRED WHICH WERE SUCCESSFULLY TREATED. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 15359795 ↗
• InjuryAug 18, 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 FOUR MONTHS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, RESTENOSIS OF THE TARGET LESION OCCURRED AND WAS SUCCESSFULLY TREATED WITH STANDARD PTA. THE TARGET LESION REQUIRED RE-INTERVENTION, THE RE-INTERVENTION WAS SUCCESSFUL AND THE PATIENT RECOVERED. IT WAS FURTHER REPORTED THAT APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, THROMBOSIS WAS DIAGNOSED. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND THROMBECTOMY/THROMBOLYSIS WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 15247165 ↗
• InjuryJun 14, 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 AFTER SOME TIME POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, PERIPHERAL ARTERY DISSECTION OCCURRED AND WAS SUCCESSFULLY TREATED. THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14683062 ↗
• InjuryMay 15, 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, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT CEPHALIC VEIN. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE TARGET LESION WAS REPORTEDLY THROMBOSED. A THROMBECTOMY AND PERCUTANEOUS ANGIOPLASTY (PTA) WAS ATTEMPTED, BUT FAILED. A TEMPORARY HEMODIALYSIS CATHETER WAS INSERTED BY THE HCP. 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. THE EVENT IS DEEMED TO BE ONGOING. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2018-00113 AND 3006513822-2018-00114.

  Patient problems: Thrombosis

  MAUDE report 7513768 ↗
• InjuryMay 15, 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, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT CEPHALIC VEIN. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE TARGET LESION WAS REPORTEDLY THROMBOSED. A THROMBECTOMY AND PERCUTANEOUS ANGIOPLASTY (PTA) WAS ATTEMPTED, BUT FAILED. A TEMPORARY HEMODIALYSIS CATHETER WAS INSERTED BY THE HCP. 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. THE EVENT IS DEEMED TO BE ONGOING. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2018-00113 AND 3006513822-2018-00115.

  Patient problems: Thrombosis

  MAUDE report 7513765 ↗