LUTONIX® Drug Coated Balloon LX351307405FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741123313), received between Apr 30, 2018 and Nov 15, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Deflation Problem; Difficult to Remove; Material Separation; Device-Device Incompatibility; Difficult to Advance; Deflation Problem; Difficult to Remove; Material Separation; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE RADIAL ACCESS, ALLEGEDLY THERE WAS A RESISTANCE WHEN THE DRUG COATED BALLOON WAS ADVANCED OVER THE WIRE. IT WAS FURTHER REPORTED THAT BALLOON FAILED TO DEFLATE BUT AFTER SEVERAL ATTEMPTS, BALLOON WAS PUNCTURED WITH A NEEDLE THROUGH PATIENTS SKIN AND DEFLATED EVENTUALLY. REPORTEDLY, THE PHYSICIAN FELT RESISTANCE WHILE REMOVING THE BALLOON THROUGH 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 12809825 ↗
• MalfunctionApr 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO THREAD OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THERE WAS AN ALLEGED WHITE RESIDUE/FIBERS COMING OUT THE END OF THE BALLOON AND COVERING WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723629 ↗
• MalfunctionApr 26, 2021Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO THREAD OVER THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723621 ↗
• MalfunctionApr 26, 2021Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO THREAD OVER THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723543 ↗
• MalfunctionApr 26, 2021Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ALLEGED WHITE RESIDUE/FIBERS COMING OUT THE END OF THE BALLOON AND COVERING WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723538 ↗
• MalfunctionApr 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED. THE HEALTH CARE PROFESSIONAL (HCP) INFLATED THE BALLOON TO NOMINAL PRESSURE, WHILE TREATING ATHEROSCLEROSIS OF THE NATIVE ARTERY IN THE LOWER EXTREMITY. THE HCP REMOVED THE LUTONIX DCB AND USED ANOTHER BALLOON TO COMPLETE THE PATIENT'S PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL EVENT INFORMATION AND PATIENT DEMOGRAPHICS WERE UNAVAILABLE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473371 ↗