LUTONIX® 035 Drug Coated Balloon PTA Catheter LX35751240VRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741135545), received between Oct 26, 2017 and Oct 8, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  ON (B)(6) 2025, A 73-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 035AV DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON RUPTURED CIRCUMFERENTIALLY AND ALLEGEDLY GOT SHREDDED OFF THE SHAFT. IT WAS FURTHER REPORTED THAT THE BALLOON GOT STUCK AND COULD NOT GET OUT OF PATIENT. A LARGER CUT WAS MADE IN THE PATIENT TO GET THE SHEATH OUT. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation

  MAUDE report 23241961 ↗
• MalfunctionOct 16, 2023Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE DRUG COATED BALLOON WAS ALLEGEDLY STUCK IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON WAS NOT DEFLATING ALL THE WAY TO PULL BACK OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17937788 ↗
• MalfunctionOct 1, 2021Difficult to Remove; Material Rupture; Material Separation; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Material Rupture; Material Separation; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY RUPTURED AND DETACHED INTO TWO PARTS. IT WAS FURTHER REPORTED THAT BALLOON AND THE DETACHED PART REMAINED INSIDE THE PATIENT WAS RETRIEVED VIA GROIN ACCESS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12560467 ↗
• MalfunctionAug 30, 2021Material Frayed; Device-Device Incompatibility; Material Deformation; Material Frayed; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD COMPATIBILITY ISSUE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DEFORMED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384696 ↗
• MalfunctionJan 18, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY GOT STUCK IN SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184392 ↗
• MalfunctionDec 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE TREATING THE NON TORTUOUS TARGET LESION IN THE BRACHIOCEPHALIC VEIN OF THE AV FISTULA. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS THROUGH THE CEPHALIC VEIN OF THE AV FISTULA WITH A 9 (B)(4) CORDIS INTRODUCER SHEATH OVER AN 035 BENTSON GUIDEWIRE. THE HCP PREDILATED THE TARGET LESION WITH AN ATLAS 12 X 40 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. ALLEGEDLY, THE LUTONIX DCB RUPTURED DURING OR IMMEDIATELY AFTER INFLATION. THE HCP REPORTEDLY DESCRIBED THE MATERIAL RUPTURE AS A PINHOLE. THE LUTONIX DCB WAS PROMPTLY AND SAFELY REMOVED FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8195878 ↗
• InjuryOct 23, 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 REVASCULARIZATION PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE SYNTHETIC AV FISTULA IN THE RIGHT FOREARM. APPROXIMATELY TWO WEEKS AFTER A REVASCULARIZATION PROCEDURE, THE PATIENT REPORTEDLY HAD DECREASED ACCESS BLOOD FLOW AND ACCESS THROMBOSIS DUE TO THE TARGET LESION BEING REOCCLUDED. A CLINICALLY DRIVEN REVASCULARIZATION INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA ), THROMBECTOMY, PLACEMENT OF A BARE METAL STENT, IMPLANTATION OF A STENT GRAFT AND SURGICAL REVISION WAS PERFORMED. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR INDEX PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion; Thrombosis

  MAUDE report 7995872 ↗
• InjuryJun 27, 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 BRACHIOCEPHALIC 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 7641481 ↗
• 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 BRACHIOCEPHALIC 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 7481207 ↗
• InjuryMar 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 BRACHIOCEPHALIC VEIN IN THE LEFT UPPER ARM. 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 7309615 ↗
• InjuryOct 26, 2017Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT DEFLATE, AFTER TREATMENT OF THE AV CIRCUIT OUTFLOW TRACT IN THE CEPHALIC VEIN. THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS IN THE ANTECUBITAL SPACE THROUGH THE CEPHALIC VEIN WITH A CORDIS 10 FRENCH INTRODUCER SHEATH OVER A BOSTON AMPLATZ GUIDEWIRE. THE HCP REPORTEDLY PREDILATED THE TARGET LESION WITH A 12 MM X 40 MM MUSTANG BALLOON. ALLEGEDLY, THE LUTONIX DCB WAS PREPARED IN THE NORMAL FASHION AND THE BALLOON PROTECTOR WAS REMOVED WITHOUT ISSUES. THE HCP ADVANCED THE LUTONIX DCB, UNDER NEGATIVE PRESSURE, TO THE TARGET LESION SUCCESSFULLY. THE LUTONIX DCB WAS ALLEGEDLY INFLATED TO 9 ATMOSPHERES (ATMS), WITH A 75% SALINE/25% CONTRAST SOLUTION, ONCE FOR TWO MINUTES. ONCE THE TREATMENT WAS COMPLETED, THE BALLOON WOULD NOT DEFLATE. THE HCP REPORTEDLY APPLIED NEGATIVE PRESSURE SEVERAL TIMES, BUT THE INFLATION SOLUTION WAS NOT COMPLETELY REMOVED FROM THE BALLOON. THE HCP ALLEGEDLY BEGAN TO RETRACT THE LUTONIX DCB FROM THE ACCESS CIRCUIT, WITHOUT COMPLETELY DEFLATING THE BALLOON. THE HCP HAD DIFFICULTY RETRACTING THE BALLOON PORTION OF THE LUTONIX DCB INTO THE

  Patient problems: Injury

  MAUDE report 6979542 ↗