LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35100860VRecalls & reported problems
Lutonix, Inc. · Lutonix® AV Drug Coated Balloon PTA Catheter 8x60x100 · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741135712), received between Dec 12, 2018 and Dec 12, 2018 — classified as 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
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2018Material Rupture; Material Rupture
IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE TREATING A NON CALCIFIED TARGET LESION LOCATED IN THE AV FISTULA. THE HEALTH CARE PROFESSIONAL (HCP) GAINED ACCESS FROM THE PATIENT'S ARM WITH A 7 FRENCH BOSTON SCIENTIFIC SUPER SHEATH OVER AN 035 BENTSON GUIDEWIRE. REPORTEDLY, THE HCP PREDILATED THE TARGET LESION WITH A 8 X 60MM MUSTANG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE HCP REACHED THE TARGET LESION WITH THE LUTONIX DCB AND ATTEMPTED TO INFLATE THE BALLOON. REPORTEDLY ON THE FIRST INFLATION, THE LUTONIX DCB ALLEGEDLY RUPTURED AFTER ACHIEVING 8 ATMOSPHERES (ATMS) OF PRESSURE. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL LUTONIX DCB. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8156176 ↗
Other Drug-coated peripheral transluminal angioplasty catheter devices
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575760VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter2 deaths60 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575860VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter3 deaths54 reports
- IN.PACT™ AV IAV06008008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter1 recall1 report
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751060VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter25 reports
- IN.PACT™ AV IAV08004008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter21 reports
- IN.PACT™ AV IAV08006008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter19 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575660VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter1 death19 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575840VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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