Lutonix® Drug Coated Balloon BSCLX35130440Recalls & reported problems
Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter .035 130cm 4x40mm · 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 00801741098406), received between Nov 11, 2015 and Nov 11, 2015 — 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.
MalfunctionNov 11, 2015Material Rupture
IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED. THE HCP DID NOT PRE-DILATE THE TARGET LESION AND THE LUTONIX DCB WAS ADVANCED WITHOUT NEGATIVE PRESSURE BEING APPLIED TO THE BALLOON. THE HCP REACHED THE TARGET LESION WITHOUT DIFFICULTY. AFTER ATTEMPTING TO INFLATE THE BALLOON TO TREAT THE LESION, THE BALLOON RUPTURED. THE LUTONIX DCB WAS REPORTEDLY REMOVED WITHOUT DIFFICULTY AND ON VISUAL INSPECTION BY THE HCP; A LONGITUDINAL RUPTURE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER LUTONIX DCB TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5219168 ↗
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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