LUTONIX® Drug Coated Balloon LX357561005FRecalls & reported problems
Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 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 00801741122897), received between Dec 7, 2018 and Dec 7, 2018 — 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.
InjuryDec 7, 2018Adverse 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 DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE HEAVILY CALCIFIED LESION LOCATED IN THE LEFT POPLITEAL ARTERY. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL ARTERY WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Reocclusion
MAUDE report 8144051 ↗
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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