LUTONIX® Drug Coated Balloon LX351304405FRecalls & reported problems
Lutonix, Inc. · LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741123139), received between Aug 8, 2017 and Aug 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
- Material Rupture1
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE RECEIVED PACKAGE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INSIDE AND OUTSIDE OF THE BOX WERE DEMOLISHED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20093069 ↗MalfunctionAug 8, 2017Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS UNABLE TO INFLATE ONCE DELIVERED TO THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) USED AN IPSILATERAL APPROACH TO TREAT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. THE VESSEL WAS NOT TORTUOUS IN NATURE. THE HCP PREPARED THE LUTONIX DCB AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES. REPORTEDLY, NEGATIVE PRESSURE WAS NOT APPLIED DURING PREPARATION AND THERE WAS NO DAMAGE TO THE CATHETER. SINCE THE BALLOON DID NOT INFLATE, THE HCP REMOVED THE BALLOON WITHOUT ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. REPORTEDLY, THE HCP VISUALLY INSPECTED THE BALLOON AFTERWARDS AND NOTED "A SMALL LESION AT THE BALLOON". THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6775730 ↗
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
- LUTONIX® Drug Coated Balloon LX351305150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter117 reports
- LUTONIX® Drug Coated Balloon LX351306150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter75 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page