LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575580VRecalls & reported problems
Lutonix, Inc. · Lutonix® AV Drug Coated Balloon PTA Catheter 5x80x75 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741135361), received between Sep 6, 2023 and Sep 6, 2023 — classified as 1 injury.
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
Patient problems
- Restenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF CLINICAL TRIAL THAT FOUR MONTHS AND FOURTEEN DAYS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER IN THE BASILIC VEIN, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF RECURRENT STENOSIS ON TARGET LESION BASILIC VEIN WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION DUE TO DECREASED ACCESS BLOOD FLOW AND PROLONGED BLEEDING. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY AND OTHER DRUG COATED BALLOON CATHETER PROCEDURES WERE PERFORMED TO TREAT DECREASED ACCESS BLOOD FLOW AND PROLONGED BLEEDING. THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RESOLVED. IT WAS FURTHER REPORTED THAT FIVE MONTHS AND TWENTY-EIGHT DAYS POST THE INDEX PROCEDURE COMPLETION, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF RECURRENT STENOSIS IN THE CEPHALIC VEIN WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION DUE TO DECREASED ACCESS BLOOD FLOW. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINOUS ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT DECREASED ACCESS BLOOD FLOW. THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RESOLVED. FURTHERMORE, EI
Patient problems: Restenosis
MAUDE report 17688968 ↗
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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