LUTONIX® Drug Coated Balloon LX3513072205FRecalls & reported problems
Lutonix, Inc. · Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F · Class 3
All models of LUTONIX Drug Coated Balloon (107)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741163470), received between Nov 11, 2020 and Feb 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Inflation Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY HAD A HOLE IN IT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330977 ↗MalfunctionJun 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON WAS ALLEGEDLY RUPTURED WHEN IT REACHED NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508489 ↗MalfunctionNov 11, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PTA PROCEDURE THROUGH THE COMMON FEMORAL ARTERY, THE BALLOON WAS ALLEGEDLY TWISTED AND COULD NOT INFLATE FULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10821485 ↗
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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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