LUTONIX® Drug Coated Balloon LX3513071505FRecalls & reported problems
Lutonix, Inc. · Lutonix 035 DCB, 7mm x 150mm 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 00801741163463), received between May 26, 2022 and Jun 11, 2024 — 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
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Failure to Advance1
- Material Deformation1
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.
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 19508490 ↗MalfunctionFeb 1, 2023Material Rupture; Failure to Advance; Device-Device Incompatibility; Material Deformation; Material Rupture; Failure to Advance; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON WAS ALLEGEDLY UNABLE TO BE ADVANCED TO THE TARGET LESION. IT WAS FURTHER REPORTED THAT THE DRUG COATED BALLOON ALLEGEDLY STUCK ON THE WIRE. REPORTEDLY, UPON REMOVAL OF THE DEVICE, IT WAS FOUND THAT THE BALLOON ALLEGEDLY SNAGGED ON THE CATHETER AND LOOKED LIKE IT WAS STARTING TO ELONGATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16277554 ↗MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CENTRAL PART OF THE DRUG-COATED BALLOON ALLEGEDLY BROKEN INSIDE THE PATIENT VESSEL. IT WAS FURTHER REPORTED THAT FRAGMENT OF THE BALLOON REMAINS INSIDE THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14510995 ↗
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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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