LUTONIX® Drug Coated Balloon LX1813051505FRecalls & reported problems
Lutonix, Inc. · LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM · 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 00801741177620), received between Aug 14, 2019 and Nov 20, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (2 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
- Material Twisted/Bent2
- Inflation Problem1
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.
MalfunctionNov 20, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, THE BALLOON WAS DEFLATED AND INFLATED FOR THE SECOND TIME. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10873529 ↗MalfunctionAug 14, 2019Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE DRUG COATED BALLOON ALLEGEDLY TWISTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8893918 ↗
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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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