LUTONIX® Drug Coated Balloon LX1813062205FRecalls & reported problems
Lutonix, Inc. · LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM · Class 3
All models of LUTONIX Drug Coated Balloon (107)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This LUTONIX drug-coated balloon catheter is used to reopen narrowed arteries, including in dialysis access procedures. The 27 reports mostly describe the balloon twisting or kinking during the procedure so it would not open fully, plus one report of the balloon coming apart from the catheter when it was removed from the package. No deaths and no injuries are reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741177705), received between May 16, 2019 and Mar 2, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (22 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
- Inflation Problem22
- Material Twisted/Bent22
- Material Rupture3
- Detachment of Device or Device Component1
- Material Deformation1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Inflation Problem; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE BY USING THE LUTONIX DRUG COATED BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481187 ↗MalfunctionDec 8, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING LUTONIX 018 DRUG COATED DILATATION CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY FAILED TO OPEN FULLY LEAVING A SMALL PINCH ON THE BALLOON. FURTHER, THE BALLOON WAS INFLATED AND DEFLATED AGAIN TO GET THE AREA TO OPEN AND WAS FURTHER SLIGHTLY OVER-INFLATED WHEN IT WAS FULLY OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23740432 ↗MalfunctionNov 25, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRUG COATED BALLOON ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED DILATATION CATHETER. DURING THE PROCEDURE THE BALLOON ALLEGEDLY FAILED TO OPEN DURING INFLATION AND LEAVING A SMALL PINCH IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23641579 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6)2025, A PATIENT UNDERWENT A PERCUTANEOUS DRUG COATED BALLOON ANGIOPLASTY (DCB) PROCEDURE USING THE LUTONIX DRUG COATED DILATATION CATHETER. DURING THE PREPARATION UPON REMOVAL FROM PACKAGE IT WAS NOTED THAT THE BALLOON WAS DETACHED FROM THE CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050368 ↗MalfunctionSep 8, 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 DILATATION CATHETER. DURING THIS PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY TWISTED IN THE MIDDLE OF THE PROCEDURE WHICH RESULTED IN AN INCOMPLETE INFLATION OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989892 ↗MalfunctionAug 14, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON (DCB) PTA CATHETER. DURING THE PROCEDURE, THE BALLOON FAILED TO OPEN, RESULTING IN A PINCHED BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803380 ↗MalfunctionJan 22, 2024Unraveled Material; Unraveled Material
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON WAS ALLEGEDLY FOUND TO BE UNRAVELED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550516 ↗MalfunctionJan 11, 2024Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED DISTALLY AND WOULD NOT UNTWIST IN THE BODY. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DEFLATED BALLOON, MOVED ONE CENTIMETER AND RE-INFLATED MULTIPLE TIMES TO HAVE IT UNTWIST BUT BALLOON WOULD NOT UNTWIST. REPORTEDLY, AFTER TAKING OUT OF THE BODY, THE BALLOON UNTWISTED AFTER SEVERAL TIMES INFLATING AND DEFLATING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490597 ↗MalfunctionJan 9, 2024Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED DISTALLY AND WOULD NOT UNTWIST IN THE BODY. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DEFLATED BALLOON, MOVED ONE CENTIMETER AND RE-INFLATED MULTIPLE TIMES TO HAVE IT UNTWIST BUT BALLOON WOULD NOT UNTWIST. REPORTEDLY, AFTER TAKING OUT OF THE BODY, THE BALLOON UNTWISTED AFTER SEVERAL TIMES INFLATING AND DEFLATING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18472598 ↗MalfunctionMar 7, 2023Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16494036 ↗MalfunctionDec 14, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15984176 ↗MalfunctionDec 14, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15975187 ↗MalfunctionDec 12, 2022Inflation Problem; Material Rupture; Material Deformation; Inflation Problem; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY HAD A CRIMPED RING. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15957179 ↗MalfunctionNov 29, 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 TWISTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15875531 ↗MalfunctionNov 9, 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 ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15758154 ↗MalfunctionNov 8, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE BALLOON WAS INFLATED AT 7 NOMINAL ATM PRESSURE, THE DRUG COATED BALLOON ALLEGEDLY TWISTED IN THE CENTRAL PART OF THE BALLOON. IT WAS FURTHER REPORTED THE DEVICE WAS ALLEGEDLY HAD INFLATION ISSUE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15750972 ↗MalfunctionMay 9, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA SFA LESION, THE DRUG COATED BALLOON WAS ALLEGEDLY TWISTED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14333284 ↗MalfunctionJul 23, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO INFLATE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12215778 ↗MalfunctionJun 17, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY HAD INFLATION PROBLEM AND BALLOON GOT TWISTED IN THE MIDDLE PORTION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED AND RE-INFLATED WHICH RESULTED IN SAME ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12015347 ↗MalfunctionMay 11, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY TWISTED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11805005 ↗MalfunctionJun 30, 2020Material Rupture; Material Rupture
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10210878 ↗MalfunctionMar 2, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY TWISTED AND COULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9777528 ↗MalfunctionMar 2, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY TWISTED AND COULD NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9777527 ↗MalfunctionFeb 12, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA LEFT FEMORAL APPROACH. THE LESION SITE WAS PRE-DILATED WITH AN 018 PTA BALLOON. THE DRUG COATED BALLOON ALLEGEDLY RUPTURED AT 12ATM DURING THE FIRST INFLATION ATTEMPT. THE BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9701145 ↗MalfunctionSep 12, 2019Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE DRUG COATED BALLOON ALLEGEDLY TWISTED AND WAS DIFFICULT TO INFLATE. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9014466 ↗
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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.
How reports and recalls are matched · Editorial policy · Report an error on this page