LUTONIX® Drug Coated Balloon LX3513042205FRecalls & reported problems
Lutonix, Inc. · Lutonix 035 DCB, 4mm 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741163401), received between Feb 24, 2020 and Mar 15, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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 Rupture3
- Break1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON WAS ALLEGEDLY BROKEN AND FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21613456 ↗MalfunctionJul 1, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE WHICH LEAKED CONTRAST. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19641339 ↗MalfunctionMar 16, 2020Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY TORE INTO TWO PIECES. IT WAS FURTHER REPORTED THAT THE BALLOON HAD DIFFICULTY RETRACTING THROUGH THE SHEATH AND THE HEALTH CARE PROVIDER HAD TO PULL HARD ON THE DEVICE TO REMOVE IT FROM THE SHEATH. REPORTEDLY, THERE WAS DETACHED DEVICE MATERIAL WITHIN THE SHEATH AND ON THE GUIDEWIRE. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE DETACHED MATERIAL WAS REMOVED WITH THE SHEATH AND THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9838386 ↗MalfunctionFeb 24, 2020Break; Material Separation
ELDERLY MALE WITH HISTORY OF HYPERTENSION AND ATRIAL FIBRILLATION. OR FOR RIGHT LOWER ANGIOGRAM AND ANGIOPLASTY. THE LUTONIX BALLOON BROKE AND SEPARATED INTO TWO PIECES WHILE IN THE BODY. THE 2 PIECES OF BALLOON WERE LOCATED IN MAIN SHAFT AND THE BALLOON PORTION. THE WIRE WAS REMOVED WITH 1 PIECE OF BALLOON ON IT AND THEN THE SHEATH WAS TAKEN OUT. THE PIECE OF BALLOON WAS REMOVED. NO INJURY OBSERVED TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9744694 ↗
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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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