LUTONIX® Drug Coated Balloon LX351306405FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741123252), received between Nov 21, 2018 and Sep 10, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON WAS ALLEGEDLY COULD NOT HOLD PRESSURE AS IF THERE WAS A HOLE IN IT OR THAT IT HAD BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179232 ↗
• InjuryJul 7, 2023Adverse 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 FIVE MONTHS AND SIX DAYS POST INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, THE SUBJECT DEVELOPED ADVERSE EVENT RADIOCEPHALIC ARTERIOVENOUS FISTULA LOW TRANSONIC FLOW, A STENOSIS IN VENOUS OUTFLOW WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. IT WAS FURTHER REPORTED THAT THE SUBJECT HAD TARGET LESION RESTENOSIS IN CEPHALIC VEIN WITH MAXIMUM INITIAL STENOSIS OF EIGHTY PERCENT. STANDARD PERCUTANEOUS TRANSLUMINOUS ANGIOPLASTY AND OTHER DRUG COATED BALLOON CATHETER WERE USED FOR TREATMENT. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS WAS CREATED, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF ZERO PERCENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 17281180 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT ARM AV FISTULA, THE BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE AT 11ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10282329 ↗
• MalfunctionMay 2, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 6 ATMOSPHERES (ATMS) WHILE TREATING THE IN-STENT TARGET LESION OF THE DISTAL LEFT COMMON ILIAC ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS. THE HCP DID NOT PREDILATE THE IN-STENT TARGET LESION. THE STENT WAS INTACT AND DID NOT APPEAR TO BE FRACTURED. THE HCP REPORTEDLY ADVANCED THE LUTONIX DCB TO THE TARGET LESION IN THE ZILVER PTX STENT, AND INFLATED THE BALLOON TO 6 ATMS. AFTER THE LUTONIX DCB ALLEGEDLY RUPTURED, REPORTEDLY IT WAS REMOVED IN ITS ENTIRETY WITHOUT DIFFICULTY. THE HCP COMPLETED THE PROCEDURE WITH ANOTHER LUTONIX DCB. IN THE OPINION OF THE HCP, THE INFLATION WITHIN THE ZILVER STENT WAS RELATED TO THE NATURE OF THE RUPTURE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573861 ↗
• InjuryFeb 12, 2019Adverse 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 28 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. 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 8333655 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED. APPROXIMATELY TWO WEEKS LATER, A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, BUT NOT RELATED TO THE PROCEDURE. 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 8096318 ↗