LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575740VRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741135422), received between Dec 7, 2021 and Sep 10, 2024 — classified as 2 injuries, 2 malfunctions.

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

• InjurySep 10, 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 SOMETIME POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE CEPHALIC VEIN AT OUTFLOW NEAR CANNULATION ZONE VIA THE LEFT UPPER ARM, THE SUBJECT HAD ADVERSE EVENT OF PSEUDOANEURYSM ON PRE-DILATION AND ANEURYSM ON CEPHALIC VEIN. IT WAS FURTHER REPORTED THAT ONE MONTH AND ELEVEN DAYS AFTER INDEX PROCEDURE, THE SUBJECT HAD SERIOUS ADVERSE EVENT DUE TO CEPHALIC VEIN RESTENOSIS AND ACCESS CIRCUIT THROMBOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. FURTHERMORE, ONE MONTH AND NINETEEN DAYS AFTER INDEX PROCEDURE, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT CEPHALIC VEIN RESTENOSIS AND ACCESS CIRCUIT THROMBOSIS. TREATMENT REINTERVENTION WAS SUCCESSFUL, NEW ACCESS WAS NOT CREATED, AND THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. REPORTEDLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES REPORTED FOR THIS SUBJECT TO DATE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aneurysm; Pseudoaneurysm; Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 20179463 ↗
• InjuryAug 28, 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 ONE YEAR AND TWENTY-FIVE DAYS POST INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER IN THE CEPHALIC VEIN, THE SUBJECT DEVELOPED A SERIOUS ADVERSE EVENT OF OCCLUSION DUE TO THROMBOSIS OF THE CEPHALIC VEIN WHICH REQUIRED ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION. IT WAS FURTHER REPORTED THAT ONE YEAR, ONE MONTH, AND ONE DAY AFTER THE INDEX PROCEDURE, THE ACCESS THROMBOSIS IN THE RIGHT UPPER ARM CEPHALIC VEIN HAD A HUNDRED PERCENT INITIAL STENOSIS AND ZERO PERCENT FINAL RESIDUAL STENOSIS. FURTHERMORE, IT WAS ALSO REPORTED THAT THE SUBJECT UNDERWENT THROMBECTOMY AND SURGICAL REVISION OF RIGHT UPPER EXTREMITY THROMBOSED ARTERIOVENOUS FISTULA WITH SIX-MILLIMETER ARTEGRAFT AS AN INTERPOSITION GRAFT TO RESTORE BLOOD FLOW TO THAT ORIGINAL ARTERIOVENOUS FISTULA. THE RE-INTERVENTION WAS NOT SUCCESSFUL, AND SO A NEW ARTERIOVENOUS GRAFT ACCESS WAS SURGICALLY CREATED, AND THE OUTCOME WAS RECOVERED. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17630269 ↗
• MalfunctionNov 2, 2022Difficult to Insert; Material Rupture; Difficult to Insert; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY DIFFICULT TO PASS THROUGH SHEATH. IT WAS FURTHER REPORTED THAT THE PROXIMAL END OF THE BALLOON ALLEGEDLY PERFORATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713090 ↗
• MalfunctionDec 7, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 12947609 ↗