Lutonix 035 Drug Coated Balloon PTA Catheter LX35751260VRecalls & reported problems
Lutonix, Inc. · Lutonix 035 12X60MMx75CM · Class 3
All models of LUTONIX 035 Drug Coated Balloon PTA Catheter (19)
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 00801741202575), received between Apr 8, 2020 and Apr 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
- Difficult to Remove2
- Device Markings/Labelling Problem1
- Inflation Problem1
- Material Deformation1
- Material Rupture1
- Material Separation1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT LENGTH OF THE DRUG-COATED BALLOON WAS ALLEGEDLY NOT 75 CM AS THE PACKAGE STATES. IT WAS FURTHER REPORTED THAT USING A LONG SHEATH OF 65 CM THE BALLOON WOULD NOT SHOW IN TOTAL AND ONE OF THE DOTS WAS STILL LODGED IN THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908034 ↗MalfunctionMar 29, 2024Inflation Problem; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Inflation Problem; Difficult to Remove; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN THE SUBCLAVIAN VEIN VIA THE ARTERIOVENOUS FISTULA ACCESS, THE DRUG-COATED BALLOON ALLEGEDLY 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 19002108 ↗MalfunctionJul 23, 2020Difficult to Remove; Retraction Problem; Material Separation; Device-Device Incompatibility; Difficult to Remove; Retraction Problem; Material Separation; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE CEPHALIC, THE GUIDEWIRE ALLEGEDLY WAS UNABLE TO BE COMPLETELY LOADED THROUGH THE CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN GETTING THE BALLOON OUT OF THE SHEATH AFTER INFLATION AND THAT IT GOT STUCK IN THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING POBA. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10313082 ↗MalfunctionApr 8, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LESION IN THE SUBCLAVIAN VEIN, THE BALLOON ALLEGEDLY RUPTURED AFTER THE BALLOON PRESSURE WAS INCREASED FROM 6 ATM TO 8 ATM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9941488 ↗
Other Drug-coated peripheral transluminal angioplasty catheter devices
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- IN.PACT™ AV IAV06008008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter1 recall1 report
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35751060VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter25 reports
- IN.PACT™ AV IAV08004008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter21 reports
- IN.PACT™ AV IAV08006008PMedtronic, Inc. · Drug-coated peripheral transluminal angioplasty catheter19 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575660VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter1 death19 reports
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575840VLutonix, Inc. · Drug-coated peripheral transluminal angioplasty catheter17 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.
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