LUTONIX 035 Drug Coated Balloon PTA CatheterRecalls & reported problems across all models

We found 19 models of LUTONIX 035 Drug Coated Balloon PTA Catheter by Lutonix, Inc. in the FDA's device registry (GUDID). Together they are named in 243 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2016 and Apr 21, 2026 — classified as 7 deaths, 192 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LUTONIX 035 Drug Coated Balloon PTA Catheter problems

LUTONIX 035 Drug Coated Balloon PTA Catheter models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575760V

  Drug-coated peripheral transluminal angioplasty catheter
  2 deaths60 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575860V

  Drug-coated peripheral transluminal angioplasty catheter
  3 deaths54 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751060V

  Drug-coated peripheral transluminal angioplasty catheter
  25 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575660V

  Drug-coated peripheral transluminal angioplasty catheter
  1 death19 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575840V

  Drug-coated peripheral transluminal angioplasty catheter
  17 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575960V

  Drug-coated peripheral transluminal angioplasty catheter
  14 reports
• LUTONIX® 035 Drug Coated Balloon PTA Catheter LX35751240V

  Drug-coated peripheral transluminal angioplasty catheter
  11 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751040V

  Drug-coated peripheral transluminal angioplasty catheter
  1 death10 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575940V

  Drug-coated peripheral transluminal angioplasty catheter
  9 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575680V

  Drug-coated peripheral transluminal angioplasty catheter
  4 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575740V

  Drug-coated peripheral transluminal angioplasty catheter
  4 reports
• Lutonix 035 Drug Coated Balloon PTA Catheter LX35751260V

  Drug-coated peripheral transluminal angioplasty catheter
  4 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575640V

  Drug-coated peripheral transluminal angioplasty catheter
  3 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575540V

  Drug-coated peripheral transluminal angioplasty catheter
  2 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35756100V

  Drug-coated peripheral transluminal angioplasty catheter
  2 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX351001060V

  Drug-coated peripheral transluminal angioplasty catheter
  2 reports
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575560V

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575580V

  Drug-coated peripheral transluminal angioplasty catheter
  1 report
• LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35100860V

  Drug-coated peripheral transluminal angioplasty catheter
  1 report

Recent LUTONIX 035 Drug Coated Balloon PTA Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL ((B)(6)) THAT APPROXIMATELY ELEVEN MONTHS AND TWENTY ONE DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG COATED BALLOON CATHETER, THERE WAS DIFFICULTY IN CANNULATION DUE TO ACCESS SITE SCARRING AND CLOTS. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT POSSIBLY RELATED TO THE AV ACCESS CIRCUIT. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 24934594 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL STUDY THAT APPROXIMATELY ONE YEAR AND TWENTY-THREE DAYS POST INDEX PROCEDURE USING A LUTONIX 035 DRUG COATED BALLOON PTA CATHETER, IN THE LEFT FOREARM ON THE AXILLARY VEIN TARGET LESION, THE PATIENT HAD AN ADVERSE EVENT OF AVF CLOT. THE RELATIVITY OF THE EVENT WITH THE DEVICE, PROCEDURE OR CIRCUIT WAS NOT REPORTED. AV ACCESS CIRCUIT RE-INTERVENTION WAS NOT REQUIRED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24017768 ↗
• 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 ↗
• 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 FIFTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF ¿LUE AVF INFECTION¿. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. IT WAS FURTHER REPORTED THAT, THE PATIENT ALSO HAD AN ADVERSE EVENT OF "LUE AVF CLOT". THE RELATIVITY OF THE EVENT WITH THE DEVICE, PROCEDURE AND THE AV ACCESS CIRCUIT WAS NOT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23800554 ↗
• 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 ((B)(6)) THAT APPROXIMATELY SIXTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF ¿LEFT AVF BASILIC VEIN STENOSIS¿. REPORTEDLY, THE ADVERSE EVENT WAS RELATED TO DEVICE AND AV ACCESS CIRCUIT BUT NOT RELATED TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT A STANDARD PTA AND LUTONIX DCB WAS USED DURING RE-INTERVENTION IN THE TARGET LESION ON BASILIC VEIN WITH INITIAL STENOSIS OF 60% AND FINAL RESIDUAL STENOSIS OF 20%. THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 23800470 ↗
• InjuryNov 24, 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 EIGHT MONTHS AND TWO WEEKS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER FOR TARGET LESION STENOSIS ON THE LEFT UPPER ARM BASILIC VEIN, THE SUBJECT UNDERWENT ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM FOR AV FISTULA ANEURYSM AND PAIN WITHOUT STENOSIS. IT WAS FURTHER REPORTED THAT A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS USED IN THE RE-INTERVENTION ON THE TARGET LESION ON THE UPPER ARM BRACHIAL VEIN WITH INITIAL STENOSIS OF 0% AND FINAL RESIDUAL STENOSIS OF 0%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL. FURTHERMORE, THE SUBJECT UNDERWENT ANOTHER ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM FOR AV FISTULA ANEURYSM AND PAIN WITHOUT STENOSIS. A STANDARD PTA WAS USED IN THE RE-INTERVENTION ON THE TARGET LESION ON THE UPPER ARM BRACHIAL VEIN WITH INITIAL STENOSIS OF 0% AND FINAL RESIDUAL STENOSIS OF 0%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS CREATED.

  Patient problems: Aneurysm; Pain; Restenosis

  MAUDE report 23631971 ↗
• 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 ↗
• InjurySep 22, 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 SEVEN MONTHS AND FIVE DAYS LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DILATION CATHETER ON THE LEFT FOREARM CEPHALIC VEIN PERIANASTOMOTIC VENOUS STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF ANGIOGRAM DUE TO STENOSIS OF LEFT RADIOCEPHALIC AVF. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS NOT RELATED TO DEVICE AND PROCEDURE BUT DEFINITELY RELATED TO AV ACCESS CIRCUIT. REPORTEDLY, A AV ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED ON THE TARGET LESION ON CEPHALIC VEIN WITH INITIAL STENOSIS OF 58% AND FINAL RESIDUAL STENOSIS OF 25%. THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS CREATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 23106994 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE STUDY (AV PAS) THAT SOMETIME LATER POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING LUTONIX DRUG COATED BALLOON PTA CATHETER ON THE BASILIC VEIN OF THE LEFT UPPER ARM FOR DILATION OF STENOSIS, THE SUBJECT HAD STENOSIS ON THE TARGET VEIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 23061769 ↗
• MalfunctionSep 10, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE LUTONIX 035AV DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013186 ↗
• DeathSep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE STUDY (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 EVENTUALLY EXPIRED, DUE TO END STAGE RENAL DISEASE. THE CAUSE OF DEATH WAS NOT REPORTED AND RELATIVITY OF THE EVENT WITH THE DEVICE OR PROCEDURE IS NOT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975409 ↗
• InjuryAug 13, 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 (AV PAS / CL003301) THAT APPROXIMATELY SIX MONTHS AND A WEEK. POST INDEX PROCEDURE USING A LX35751060V LUTONIX 035AV DRUG COATED PTA DILATION CATHETER, IN THE LEFT UPPER ARM ON THE CEPHALIC VEIN TARGET LESION, THE PATIENT HAD AN ADVERSE EVENT OF OCCASIONAL LEFT-HAND NUMBNESS, TINGLING. THE RELATIVITY OF THE EVENT WITH THE DEVICE, PROCEDURE OR CIRCUIT WAS NOT REPORTED. AV ACCESS CIRCUIT RE-INTERVENTION WAS NOT REQUIRED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22792113 ↗
• InjuryAug 13, 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 TRAIL OF A LUTONIX BALLOON, THAT APPROXIMATELY FIVE MONTHS AND TWENTY-TWO DAYS POST THE PTA PROCEDURE, THE PATIENT HAD DECREASED FLOW RATE ON THE ACCESS CIRCUIT. IT WAS ALSO REPORTED THAT STENOSIS WAS IDENTIFIED ON THE TARGET LESION AND ALSO A NEW LESION WAS IDENTIFIED. THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT UNDERWENT A PTA PROCEDURE AS RE-INTERVENTION FOR THE STENOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Reduced Blood Flow; Restenosis

  MAUDE report 22791413 ↗
• InjuryAug 12, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL (B)(4) THAT APPROXIMATELY SOMETIMES POST INDEX PROCEDURE USING A LUTONIX DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN FOR TARGET LESION STENOSIS, THE SUBJECT HAD AN ADVERSE EVENT OF HEMATOMA AND STEAL SYNDROME. THE ADVERSE EVENT RELATIONSHIP TO THE DEVICE, PROCEDURE AND ARTERIOVENOUS ACCESS CIRCUIT WAS NOT REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Restenosis; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 22781642 ↗
• 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 ↗

Other Lutonix, Inc. products

• LUTONIX Drug Coated Balloon107 models · 997 reports