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LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35756100VRecalls & reported problems

Lutonix, Inc. · Lutonix® AV Drug Coated Balloon PTA Catheter 6x100x75 · Class 3

All models of LUTONIX 035 Drug Coated Balloon PTA Catheter (19)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741135415), received between Nov 21, 2016 and Jan 18, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Reocclusion1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 18, 2022Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13274260 ↗
  • InjuryNov 21, 2016Adverse 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 CATHETERS WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERIOR VENA CAVA. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SUPERIOR VENA CAVA VESSEL WAS REPORTEDLY REOCCLUDED. THE SUBJECT WAS UNDERGOING ROUTINE DIALYSIS WITHOUT DIFFICULTIES. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE DEVICE, DEFINITELY RELATED TO THE PROCEDURE, AND DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Reocclusion

    MAUDE report 6118711 ↗

Other Drug-coated peripheral transluminal angioplasty catheter devices

All Drug-coated peripheral transluminal angioplasty catheter devices →

Sources and updates

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