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LUTONIX® Drug Coated Balloon LX3513051205FRecalls & reported problems

Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x120mm 5 French · Class 3

All models of LUTONIX Drug Coated Balloon (107)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741123238), received between Sep 17, 2018 and Nov 22, 2021 — classified as 1 injury, 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

Device problems

  • Material Rupture3
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1
  • Reocclusion1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 22, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DRUG COATED BALLOON ALLEGEDLY RUPTURED. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12851618 ↗
  • MalfunctionAug 30, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12382534 ↗
  • MalfunctionMar 9, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY ACCESSED VIA CONTRALATERAL APPROACH, THE BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9808967 ↗
  • InjurySep 17, 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED. IT IS UNKNOWN AT THIS TIME, IF A REVASCULARIZATION WAS PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES, BUT NOT RELATED TO PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00196.

    Patient problems: Reocclusion

    MAUDE report 7880761 ↗

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Sources and updates

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