Lutonix® Drug Coated Balloon LX3575460Recalls & reported problems
Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741088025), received between Sep 13, 2016 and Sep 13, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2016Material Rupture; Material Rupture
IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT INFLATE AFTER THE BALLOON WAS ADVANCED TO THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED A SUCCESSFUL PREDILATION OF THE TARGET LESION. THE HCP PREPARED THE LUTONIX DCB IN THE NORMAL FASHION AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUE. THE HCP ADVANCED THE BALLOON UNDER NEGATIVE PRESSURE THROUGH A NON CALCIFIED OR TORTUOUS PATHWAY TO THE TARGET LOCATION. AFTER THE BALLOON WAS REMOVED IN ITS ENTIRETY, THE HCP NOTED THERE WAS A PINHOLE IN THE MIDDLE OF THE BALLOON. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5948046 ↗
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- 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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