LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575940VRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741135484), received between Jun 5, 2018 and Jun 7, 2025 — classified as 7 injuries, 2 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 A PATIENT UNDERWENT THE LUTONIX DRUG COATED BALLOON PROCEDURE. IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT ONE YEAR THREE MONTHS AND FIFTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER ON THE LEFT UPPER ARM CEPHALIC VEIN LESION, THE SUBJECT HAD AN ADVERSE EVENT OF PROLONGED BLEEDING. THE ADVERSE EVENT RELATIONSHIP DETAILS WERE NOT PROVIDED. REPORTEDLY, A AV ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED FOR ELEVATED VENOUS PRESSURES AND PROLONGED BLEEDING. A STANDARD PTA AND LUTONIX DCB WAS USED IN RE-INTERVENTION. THE RE-INTERVENTION WAS SUCCESSFUL AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 22163976 ↗
• InjuryJun 25, 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 TEN MONTHS AND TWO DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF STENOSIS AT CEPHALIC ARCH AND SWING ARM IN ARTERIOVENOUS FISTULA. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE UPPER ARM WITH FIFTY-TWO PERCENT INITIAL STENOSIS AND TWENTY PERCENT FINAL RESIDUAL STENOSIS. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED FOR TREATMENT. IT WAS FURTHER REPORTED THAT APPROXIMATELY ONE YEAR NINE MONTHS AND FOURTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF THROMBOSIS OF THE ARTERIOVENOUS FISTULA. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT POSSIBLY RELATED TO THE AV ACCESS CIRCUIT. FURTHERMORE, THROMBECTOMY/THROMBOLYSIS WAS PERFORMED FOR TARGET LESION WITH INITIAL STENOSIS OF HUNDRED PERCENT AND FINAL RESIDUAL STENOSIS OF SIXTY PERCENT AND ACCESS THROMBOSIS WITH INITIAL STENOSIS OF HUNDRED PERCENT AND FINAL RESIDUAL STENOSIS OF SIXTY PERCENT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. THE CURRENT STATUS OF THE PAT

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 19605145 ↗
• InjuryApr 5, 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 SIX MONTHS AND TWENTY-FOUR DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN AT CEPHALIC ARCH VIA THE RIGHT ARM ACCESS, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF OCCLUSION OF ARTERIOVENOUS ANASTOMOSIS AND VENOUS OUTFLOW SEGMENT AND THE STENOSIS OF CEPHALIC ARCH IN ARTERIOVENOUS FISTULA WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE AND THROMBECTOMY WAS PERFORMED TO TREAT CEPHALIC VEIN RESTENOSIS AND ACCESS CIRCUIT THROMBOSIS. TREATMENT RE-INTERVENTION WAS NOT SUCCESSFUL THOUGH THE PATIENT WAS UNABLE TO TOLERATE THE PROCEDURE AND NEW ACCESS WAS NOT CREATED. IT WAS FURTHER REPORTED THAT SIX MONTHS AND TWENTY-SIX DAYS POST AN INDEX PROCEDURE COMPLETION, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF ARTERIOVENOUS FISTULA MALFUNCTION DUE TO CLOT. FURTHERMORE, THE SUBJECT UNDERWENT PERMANENT DIALYSIS CATHETER PLACEMENT AT OUTSIDE HOSPITAL. MOREOVER, TEN MONTHS AND TWENTY-SEVEN DAYS POST AN INDEX PROCEDURE COMPLETION, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF DEATH. REPORTEDLY, THE SUBJECT PASSED AWAY AT HOME ON HOSP

  Patient problems: Insufficient Information; Restenosis; Thrombosis/Thrombus

  MAUDE report 19048511 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF CLINICAL TRIAL THAT THREE MONTHS AND EIGHTEEN DAYS POST INDEX PROCEDURE USING DRUG-COATED BALLOON CATHETER, SUBJECT HAD ADVERSE EVENT STENOSIS OF CEPHALIC ARCH VEIN WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. IT WAS FURTHER REPORTED THAT FIVE MONTHS SEVEN DAYS POST INDEX PROCEDURE, SUBJECT HAD ADVERSE EVENT STENOSIS OF CEPHALIC ARCH VEIN WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. REPORTEDLY, THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION HAD INITIAL MAXIMUM STENOSIS OF NINETY PERCENT. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF FIVE PERCENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 16239771 ↗
• MalfunctionFeb 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY RUPTURED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541447 ↗
• 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE BASILIC HUMERALE JUNCTION OF THE NATIVE FISTULA. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING ANGIOPLASTY AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. 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 3006513822-2018-00261.

  Patient problems: Reocclusion

  MAUDE report 8064801 ↗
• 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE BASILIC HUMERALE JUNCTION OF THE NATIVE FISTULA. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING ANGIOPLASTY AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. 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 3006513822-2018-00262.

  Patient problems: Reocclusion

  MAUDE report 8064705 ↗
• 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 HEATH 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 3006513822-2018-00205.

  Patient problems: Thrombosis

  MAUDE report 7906286 ↗
• MalfunctionJun 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A NON-CALCIFIED COMMON ILIAC ARTERY, WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, ALLEGEDLY THE BALLOON RUPTURED BEFORE BEING INFLATED TO NOMINAL PRESSURE. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS THROUGH THE PATIENT'S RIGHT GROIN WITH A 7 FRENCH CORDIS BRITE TIP INTRODUCER SHEATH OVER AN ANGIO DYNAMICS J-TIP GUIDEWIRE. THE HCP PREDILATED THE TARGET LESION WITH A BOSTON SCIENTIFIC MUSTANG BALLOON. IT IS UNKNOWN IF THE HCP APPLIED NEGATIVE PRESSURE TO THE LUTONIX DCB PRIOR TO OR DURING ADVANCEMENT TO THE TARGET LESION. THE HCP RETRACTED THE RUPTURED BALLOON WITHOUT FURTHER COMPLICATIONS. ANOTHER LUTONIX DCB WAS USED TO COMPLETE THE PATIENT'S PROCEDURE. THE SAMPLE WILL BE REQUESTED TO BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571344 ↗