LUTONIX® Drug Coated Balloon LX35757100VRecalls & reported problems
Lutonix, Inc. · Lutonix 035 7X100MMX75CM · 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 00801741187704), received between Jan 29, 2024 and Jan 29, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Restenosis1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT FIVE MONTHS AND EIGHT DAYS POST AN INDEX PROCEDURE USING A DRUG-COATED BALLOON CATHETER, IN THE CEPHALIC VEIN AT THE CANNULATION ZONE, THE SUBJECT HAD AN ADVERSE EVENT OF CEPHALIC VEIN RESTENOSIS AND WAS TREATED WITH AN AV ACCESS CIRCUIT REINTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND A DRUG COATED BALLOON CATHETER WERE USED TO TREAT THE TARGET LESION. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE OUTCOME WAS RESOLVED. IT WAS FURTHER REPORTED THAT ONE YEAR, TWO MONTHS AND TWENTY-FOUR DAYS POST AN INDEX PROCEDURE USING A DRUG COATED BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF FISTULOGRAM, RECANALIZATION AND ANGIOPLASTY AND THROMBOSIS OF CEPHALIC ARCH, JUXTA-ANASTOMOTIC STENOSIS AND WAS TREATED WITH AN AV ACCESS CIRCUIT RE-INTERVENTION. REPORTEDLY, STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT GRAFT PLACEMENT, LUTONIX DCB AND THROMBECTOMY/THROMBOLYSIS WERE USED TO TREAT THE TARGET LESION WITH INITIAL STENOSIS OF 60% AND FINAL RESIDUAL STENOSIS OF 3% AND ACCESS THROMBOSIS OF 40% AND FINAL RESIDUAL STENOSIS OF 33%. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL, AND THE CURRENT
Patient problems: Restenosis; Thrombosis/Thrombus
MAUDE report 18593689 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page