LUTONIX® Drug Coated Balloon BSLX351307605FRecalls & reported problems
Lutonix, Inc. · BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741123924), received between Sep 11, 2017 and Sep 11, 2017 — 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
- Scratched Material1
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 11, 2017Material Rupture; Scratched Material; Material Rupture; Scratched Material
IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 11 ATMOSPHERES (ATMS) WHILE TREATING THE CALCIFIED TARGET LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO TREAT THE TARGET LESION. REPORTEDLY, THE HCP PREDILATED THE TARGET LESION PRIOR TO THE LUTONIX DCB TREATMENT. ALLEGEDLY, THE LUTONIX DCB WAS ENTIRELY REMOVED FROM THE PATIENT WITHOUT ISSUES. THE HCP SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER LUTONIX DCB OF THE SAME SIZE. THE HCP DID NOT HAVE AN OPINION WHETHER THE PATIENT'S ANATOMY CAUSED OR CONTRIBUTED TO THE LUTONIX DCB'S MATERIAL RUPTURE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6857231 ↗
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- 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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