LUTONIX® Drug Coated Balloon LX351307605FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741123320), received between Mar 5, 2019 and Jul 16, 2025 — classified as 5 malfunctions.

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON (DCB) PTA CATHETER. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING INFLATION AT APPROXIMATELY 2 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517029 ↗
• MalfunctionAug 14, 2024Deflation Problem; Leak/Splash; Difficult to Remove; Deflation Problem; Leak/Splash; Difficult to Remove

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY DOES NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON COULD NOT BE REMOVED FROM 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 19980579 ↗
• MalfunctionApr 26, 2021Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY FAILED TO THREAD OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723798 ↗
• MalfunctionApr 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE WHITE RESIDUE/FIBERS WAS ALLEGEDLY 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 11723797 ↗
• MalfunctionMar 5, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY HAD A PINHOLE MATERIAL RUPTURE IN THE PROXIMAL END OF THE BALLOON. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH AT THE RIGHT FEMORAL ARTERY TO TREAT THE TARGET LESION IN THE LEFT COMMON FEMORAL ARTERY. THE USE OF A LUTONIX 035 DCB IN THE COMMON FEMORAL ARTERY IS NOT APPROVED PER THE INDICATIONS FOR USE (IFU). THE HCP USED A 45 CM 5 FRENCH TERUMO DESTINATION INTRODUCER SHEATH OVER AN 035 COOK 360 J-SHAPED GUIDEWIRE FOR PATIENT ACCESS. REPORTEDLY, THE HCP PREDILATED THE TARGET LESION. THE HCP PREPARED THE LUTONIX DCB IN THE NORMAL FASHION AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES. DURING PREPARATION OF THE LUTONIX DCB, THE HCP NOTICED A WRINKLE NEAR THE PROXIMAL END OF THE BALLOON. REPORTEDLY, THE HCP ATTEMPTED THE FIRST INFLATION OF THE LUTONIX DCB, BUT THE BALLOON IMMEDIATELY STARTED TO LOOSE PRESSURE. THE HCP REMOVED THE LUTONIX DCB FROM THE PATIENT, AND REPORTED A PINHOLE MATERIAL RUPTURE IN THE PROXIMAL END OF THE BALLOON. THE LUTONIX DCB WAS REMOVED WITHOUT ISSUES AND NO ASSOCIATED VESSEL DAMAGE. IN THE OPINION OF THE HCP, THE ANATOMY DID NOT PL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8392922 ↗