LUTONIX® Drug Coated Balloon LX357561205FRecalls & reported problems
Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x120mm 5 French · 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 00801741122903), received between Jul 16, 2019 and Jul 16, 2019 — 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
- Reocclusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY THAT A LUTONIX DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE RIGHT FEMORAL ARTERY. IT WAS FURTHER REPORTED THAT APPROXIMATELY 9-MONTH POST PROCEDURE, REOCCLUSION WAS IDENTIFIED IN THE TARGET LESION AND A REVASCULARIZATION WAS PERFORMED SUCCESSFULLY. THE INVESTIGATOR DETERMINED THAT THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE, BUT NOT RELATED TO THE STUDY DEVICE.
Patient problems: Reocclusion
MAUDE report 8795743 ↗
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
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- Ranger™ H74939419502010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Ranger™ H74939419602010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Lutonix® Drug Coated Balloon LX351305100Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter66 reports
- IN.PACT™ Admiral™ ADM06004013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall12 reports
- IN.PACT™ Admiral™ ADM06015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall11 reports
- IN.PACT™ Admiral™ ADM04015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall8 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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