LUTONIX Drug Coated BalloonRecalls & reported problems across all models
Lutonix, Inc. · 107 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
LUTONIX Drug Coated Balloon models — page 2
107 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- LUTONIX® Drug Coated Balloon LX1813051005FDrug-coated peripheral transluminal angioplasty catheter1 report
- LUTONIX® Drug Coated Balloon LX1813061005FDrug-coated peripheral transluminal angioplasty catheter1 report
- LUTONIX® Drug Coated Balloon LX1813071005FDrug-coated peripheral transluminal angioplasty catheter1 report
- LUTONIX® Drug Coated Balloon LX1813071505FDrug-Eluting Peripheral Transluminal Angioplasty Catheter1 report
- LUTONIX® Drug Coated Balloon LX351306220Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 report
- LUTONIX® Drug Coated Balloon LX1813043005FDrug-Eluting Peripheral Transluminal Angioplasty Catheter1 report
- LUTONIX® Drug Coated Balloon LX35757100VDrug-coated peripheral transluminal angioplasty catheter1 report
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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