LUTONIX® Drug Coated Balloon LX1813063005FRecalls & reported problems
Lutonix, Inc. · Lutonix 018 6X300MMX130CM · 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 during angioplasty procedures. Reports mostly describe the balloon twisting or folding during inflation so it does not inflate fully, with trouble deflating and occasional rupture. There are 23 reports that name its identifier, with no deaths and no injuries. 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
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741184727), received between Oct 1, 2020 and Apr 8, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (19 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 Problem19
- Material Twisted/Bent19
- Deflation Problem3
- Difficult to Remove2
- Failure to Advance2
- Material Rupture2
- Device-Device Incompatibility1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Inflation Problem; Material Twisted/Bent
ON (B)(6), 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY TWISTED DURING INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24814083 ↗MalfunctionMar 16, 2026Inflation Problem; Material Twisted/Bent
ON (B)(6) 2026, A 60-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY TWISTED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603600 ↗MalfunctionFeb 9, 2026Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, AN 80 YEAR OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE LUTONIX 018 DRUG COATED BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY TWISTED AND WAS TROUBLE DEFLATING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24289671 ↗MalfunctionFeb 5, 2026Inflation Problem; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE LUTONIX 018 DRUG COATED BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY TWISTED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265380 ↗MalfunctionFeb 5, 2026Inflation Problem; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WRAPPED IN DEPLOYMENT AND NOT INFLATE FULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265302 ↗MalfunctionDec 12, 2025Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRUG-COATED BALLOON ANGIOPLASTY (DCB) PROCEDURE USING THE LUTONIX 018 DRUG-COATED DILATATION CATHETER. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY FAILED INFLATE, LEAVING A SMALL PINCH IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788174 ↗MalfunctionNov 19, 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 BALLOON CATHETER. DURING THE PROCEDURE THERE WAS TIGHT PINCH MIDWAY IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE, AS IT DID NOT POSE ANY DANGER TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23592095 ↗MalfunctionAug 25, 2025Deflation Problem; Inflation Problem; Material Twisted/Bent; Deflation Problem; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, 86-YEAR-OLD MALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY VIA CONTRALATERAL APPROACH USING THE LUTONIX 018 DRUG COATED DILATATION CATHETER IN WHICH THE BALLOON ALLEGEDLY GOT TWISTED IN 2 AREAS AND TROUBLE DEFLATING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881927 ↗MalfunctionAug 18, 2025Inflation Problem; Difficult to Remove; Material Twisted/Bent; Inflation Problem; Difficult to Remove; 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, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY FAILED TO OPEN FULLY DURING INFLATION, LEAVING A SMALL PINCH IN THE BALLOON. IT WAS FURTHER REPORTED THAT BALLOON WAS DEFLATED AND STRUGGLED TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22824865 ↗MalfunctionJun 10, 2025Deflation Problem; Inflation Problem; Material Twisted/Bent; Deflation Problem; Inflation Problem; Material Twisted/Bent
ON (B)(6) 2025, A 69-YEAR-OLD FEMALE PATIENT UNDERWENT A PROCEDURE USING THE LUTONIX 018 DRUG COATED BALLOON (DCB) PTA CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY TWISTED DURING INFLATION AND HAD TROUBLE IN DEFLATING. IT WAS FURTHER REPORTED THAT TRIED RE-INFLATING IT TWICE AND POPPED IT WITH ANOTHER WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175673 ↗MalfunctionApr 22, 2025Material Rupture; Failure to Advance; Material Rupture; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA RIGHT FEMORAL ACCESS, THE DRUG-COATED BALLOON ALLEGEDLY DID NOT CROSS THE LESION TO THE INTENDED TREATMENT SITE IN AN OPEN VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21879030 ↗MalfunctionDec 24, 2024Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE DRUG-COATED BALLOON WAS ALLEGEDLY TWISTED IN TWO SPOTS. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED AND REINFLATED AND ITS STILL TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21009700 ↗MalfunctionOct 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY NEVER HELD PRESSURE ON INFLATION AND GOT BLOOD RETURN FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436944 ↗MalfunctionFeb 29, 2024Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT GROIN, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18808824 ↗MalfunctionAug 6, 2023Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17467301 ↗MalfunctionJun 25, 2023Difficult to Insert; Material Puncture/Hole; Failure to Advance; Device-Device Incompatibility; Difficult to Insert; Material Puncture/Hole; Failure to Advance; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE GUIDEWIRE WAS ALLEGEDLY FAILED TO GO THROUGH THE WIRE LUMEN. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY PROTRUDED THROUGH THE EITHER SIDE OF THE NYLON MATERIAL ON THE BALLOON OR THE PEEL AWAY PROTECTOR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196165 ↗MalfunctionNov 30, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH COMMON FEMORAL ARTERY CONTRALATERAL APPROACH, THE DEVICE ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED 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 15884090 ↗MalfunctionDec 30, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT SUPERFICIAL FEMORAL ARTERY THROUGH CONTRALATERAL APPROACH, THE DRUG COATED BALLOON ALLEGEDLY HAD INFLATION ISSUE AND WRAPPED UPON ITSELF. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13117366 ↗MalfunctionJun 10, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SFA VIA ANTIGRADE APPROACH, THE DEVICE ALLEGEDLY TWISTED AND HAD AN INFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11972520 ↗MalfunctionDec 21, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DRUG COATED BALLOON ANGIOPLASTY PROCEDURE THROUGH LEFT SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY HAD AN INFLATION ISSUE AND MATERIAL TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11044516 ↗MalfunctionDec 3, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE BALLOON ALLEGEDLY TWISTED AND FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10939659 ↗MalfunctionOct 1, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH SUPERFICIAL FEMORAL ARTERY, THE DRUG-COATED BALLOON WAS ALLEGEDLY FAILED TO INFLATE AND TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10612705 ↗
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
- LUTONIX® Drug Coated Balloon LX351305150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter117 reports
- LUTONIX® Drug Coated Balloon LX351306150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter75 reports
- Ranger™ H74939419502010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Ranger™ H74939419602010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Lutonix® Drug Coated Balloon LX351305100Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter66 reports
- IN.PACT™ Admiral™ ADM06004013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall12 reports
- IN.PACT™ Admiral™ ADM06015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall11 reports
- IN.PACT™ Admiral™ ADM04015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall8 reports
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