LUTONIX® Drug Coated Balloon LX1813072205FRecalls & reported problems
Lutonix, Inc. · Lutonix 018 7X220MMX130CM · Class 3
All models of LUTONIX Drug Coated Balloon (107)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741177774), received between Sep 17, 2020 and Aug 14, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (13 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/Bent13
- Inflation Problem12
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON (DCB) PTA CATHETER. DURING THE PROCEDURE, THE BALLOON FAILED TO DEPLOY FULLY. IT WAS FURTHER REPORTED THAT PROPER TECHNIQUE WAS APPLIED TO ATTEMPT TO GET FULL INFLATION WITHOUT SUCCESS AND THE PINCHED AREA REMAINED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22802561 ↗MalfunctionMar 12, 2025Material Rupture; Material Twisted/Bent; Material Rupture; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY GOT WRAPPED. IT WAS FURTHER REPORTED THAT ALLEGEDLY THE SAME THING HAPPENED WHILE TRIED TO PUT ANOTHER ONE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580914 ↗MalfunctionAug 30, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CENTER OF THE DRUG COATED BALLOON WAS ALLEGEDLY TWISTED AND FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12381749 ↗MalfunctionSep 18, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10552997 ↗MalfunctionSep 18, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10552995 ↗MalfunctionSep 18, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10552994 ↗MalfunctionSep 18, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10552843 ↗MalfunctionSep 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546098 ↗MalfunctionSep 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546097 ↗MalfunctionSep 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546011 ↗MalfunctionSep 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546010 ↗MalfunctionSep 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546009 ↗MalfunctionSep 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546008 ↗
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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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