LUTONIX® Drug Coated Balloon LX1813053005FRecalls & reported problems
Lutonix, Inc. · Lutonix 018 5X300MMX130CM · Class 3
All models of LUTONIX Drug Coated Balloon (107)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741184710), received between Jan 28, 2021 and Mar 26, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 Twisted/Bent7
- Inflation Problem6
- Failure to Advance2
- Material Rupture2
- Deflation Problem1
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Deflation Problem; Inflation Problem; Material Twisted/Bent; Deflation Problem; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON WAS ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. REPORTEDLY, THE BALLOON WAS ALLEGEDLY INFLATED AND DEFLATED SEVERAL TIMES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21695374 ↗MalfunctionMar 12, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DRUG COATED BALLOON ALLEGEDLY DEVELOPED A SMALL KINK IN MIDWAY DURING INFLATION. IT WAS FURTHER REPORTED THAT THE DRUG COATED BALLOON ALLEGEDLY TWISTED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21581942 ↗MalfunctionOct 1, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG-COATED BALLOON ALLEGEDLY LEAKING FROM THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20342499 ↗MalfunctionJun 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19482561 ↗MalfunctionApr 26, 2023Failure to Advance
DEVICE WOULDN'T ADVANCE THROUGH SHEATH FOR A SECOND PASS. NEW CATHETER OPENED AND WORKED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16815218 ↗MalfunctionDec 13, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; 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 WRAPPED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15967292 ↗MalfunctionNov 14, 2022Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY, THE DRUG-COATED BALLOON ALLEGEDLY FAILED TO ADVANCE OVER THE WIRE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE. REPORTEDLY, THE CATHETER SHAFT GOT DETACHED AND THE WHOLE DEVICE WAS REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15787054 ↗MalfunctionSep 20, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY VIA LEFT FEMORAL ARTERY, THE DRUG-COATED BALLOON ALLEGEDLY HAD INFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT TWISTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15454310 ↗MalfunctionFeb 15, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY (SFA), THE DRUG COATED BALLOON ALLEGEDLY HAD DIFFICULTY TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT UPON REACHING THE TARGET, THE DRUG COATED BALLOON ALLEGEDLY RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13530951 ↗MalfunctionJan 4, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE GROIN FEMORAL TO TREAT THE SFA VIA A CONTRALATERAL APPROACH, THE BALLOON ALLEGEDLY TWISTED UPON INFLATION. IT WAS FURTHER REPORTED THAT BALLOON WAS REMOVED FORM PATIENT AND TRIED TO INSERT AGAIN, HOWEVER, THE BALLOON WAS ALLEGEDLY UNABLE TO INSERT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13151450 ↗MalfunctionJun 30, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY INFLATED WITH A NAPKIN RING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12092594 ↗MalfunctionJan 28, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY TWISTED AND FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11241937 ↗
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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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