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LUTONIX® Drug Coated Balloon LX351306220Recalls & reported problems

Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm · Class 3

All models of LUTONIX Drug Coated Balloon (107)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741178733), received between Feb 13, 2019 and Feb 13, 2019 — classified as 1 injury.

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

Device problems

  • Difficult to Insert1
  • Material Rupture1
  • Retraction Problem1

Patient problems

  • Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 13, 2019Difficult to Insert; Retraction Problem; Material Rupture; Difficult to Insert; Retraction Problem; Material Rupture

    IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED LONGITUDINALLY IN THE MIDDLE OF THE BALLOON DURING TRANSIT THROUGH AN INTRODUCER SHEATH TO THE LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA).THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS. THE HCP PREPPED THE TARGET LESION BY PRE-DILATING WITH AN UNKNOWN DEVICE. REPORTEDLY, THE SALES REP IN THE PROCEDURE OPENED A 6FR LUTONIX DCB. THE HCP USED A 5X55 COOK MEDICAL ANSEL SHEATH AND A TERUMO GLIDEWIRE ADVANTAGE GUIDEWIRE TO DELIVER THE LUTONIX DCB TO THE TARGET LESION. THE HCP NOTED THAT THE DCB WAS TIGHT GOING INTO THE SHEATH. THE SALES REP INFORMED THE PHYSICIAN THAT THE WRONG BALLOON HAD BEEN OPENED FOR THE 5FR INTRODUCER SHEATH THAT WAS BEING USED, BUT THE HCP PROCEEDED WITH THE CASE. UPON REACHING THE TARGET LESION IN THE LEFT SFA, THE HCP APPLIED NEGATIVE PRESSURE WITH THE UNKNOWN INFLATION DEVICE AND ALLEGEDLY BLOOD CAME BACK INTO INFLATION DEVICE. THE HCP ATTEMPTED TO REMOVE THE RUPTURED BALLOON THROUGH THE UNDERSIZED SHEATH, BUT 1-2 CM OF THE DISTAL BALLOON WOULD NOT RETRACT THROUGH THE SHEATH. THE PHYSICIAN DECIDED

    Patient problems: Injury

    MAUDE report 8336713 ↗

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Sources and updates

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