LUTONIX® Drug Coated Balloon LX1813061505FRecalls & reported problems
Lutonix, Inc. · LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX130CM · Class 3
All models of LUTONIX Drug Coated Balloon (107)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741177699), received between Mar 19, 2022 and Mar 8, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (6 reports).
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
- Inflation Problem6
- Material Twisted/Bent6
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2023Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16501669 ↗MalfunctionFeb 21, 2023Inflation Problem; Material Deformation; Material Twisted/Bent; Inflation Problem; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16407365 ↗MalfunctionDec 14, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15975252 ↗MalfunctionNov 29, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY TWISTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15875599 ↗MalfunctionMar 22, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE PINCHING WAS NOTED IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13854325 ↗MalfunctionMar 19, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE PINCHING WAS NOTED IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13821102 ↗
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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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