LUTONIX® Drug Coated Balloon LX1813052205FRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741177637), received between May 16, 2019 and Mar 10, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 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. FURTHER, INFLATION PROBLEM WAS REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555172 ↗
• MalfunctionMar 10, 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. FURTHER, INFLATION PROBLEM WAS REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555167 ↗
• MalfunctionJan 29, 2024Crack; Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Open or Remove Packaging Material; Crack; Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE LEFT ANTERIOR TIBIAL ACCESS, THERE WAS DIFFICULTY IN REMOVING THE OUTER COVERING OF THE DRUG COATED BALLOON CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY WOULD NOT EASILY PASS THROUGH THE SHEATH. IT WAS ALSO REPORTED THAT ONCE THE BALLOON WAS DELIVERED TO THE DESIRED LOCATION AND INFLATED, THE BALLOON ALLEGEDLY RUPTURED AT THE NOMINAL PRESSURE. FURTHERMORE, THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18593915 ↗
• MalfunctionJan 14, 2023Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY TWISTED DURING INFLATION. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY HAD INFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16166619 ↗
• MalfunctionDec 6, 2022Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY TWISTED IN THE MIDDLE ON THE FIRST INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15922030 ↗
• MalfunctionJul 27, 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 IN THE MID POINT. IT WAS FURTHER REPORTED THAT THE DRUG COATED BALLOON ALLEGEDLY TWISTED UPON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109476 ↗
• MalfunctionSep 14, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH LEFT COMMON FEMORAL, THE DRUG COATED BALLOON ALLEGEDLY HAD INFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE MIDDLE OF THE BALLOON WAS ALLEGEDLY KINKED AND TWISTED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467660 ↗
• MalfunctionJul 17, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE SFA, THE LUTONIX BALLOON ALLEGEDLY FAILED TO INFLATE. IMAGING EXAMINATION SHOWED WHAT APPEARED TO BE A RUBBER BAND WRAPPED AROUND THE BALLOON. THE BALLOON WAS REMOVED WITHOUT ISSUE AND UPON TRYING TO INFLATE AGAIN, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287609 ↗
• MalfunctionJul 14, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE THROUGH SUPERFICIAL FEMORAL ARTERY BY CONTRALATERAL APPROACH, THE BALLOON ALLEGEDLY TWISTED AND FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10270354 ↗
• MalfunctionNov 1, 2019Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, ACCESSED CONTRALATERALLY, THE BALLOON ALLEGEDLY TWISTED DURING INFLATION. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269496 ↗
• MalfunctionOct 15, 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 INFLATED ABNORMALLY. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PULLED BACK A FEW CENTIMETERS AND AN ATTEMPT TO INFLATE WAS MADE, BUT THE DEVICE ALLEGEDLY DID NOT INFLATE. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195152 ↗
• MalfunctionMay 23, 2019Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A LUTONIX DCB WAS USED TO TREAT A CALCIFIED STENOSIS IN THE PATIENT'S LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT POPLITEAL ARTERY, BUT THE BALLOON ON THE LUTONIX DCB WAS TWISTED AND WOULD NOT INFLATE. THE PHYSICIAN USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS. THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED ATHERECTOMY WITH A PHOENIX DEVICE, BUT DID NOT PRE-DILATE THE LESION. REPORTEDLY, THE LUTONIX DCB WAS PREPARED PER THE IFU AND WAS DELIVERED TO THE LESION OVER A 0.018 PHOENIX LIGHT SUPPORT GUIDEWIRE THROUGH A 45CM 6 FR TERUMO DESTINATION INTRODUCER SHEATH WITH NO TWISTING MOTION DURING ADVANCEMENT. IT IS UNKNOWN IF THE LUTONIX DCB WAS ADVANCED UNDER NEGATIVE PRESSURE. THE PHYSICIAN INFLATED THE LUTONIX DCB WITH A PRESTO INDEFLATOR WITH A 2:1 CONTRAST TO SALINE SOLUTION TO 10 ATMOSPHERES (ATMS). REPORTEDLY, AN AREA OF THE BALLOON DID NOT INFLATE, SO THE PHYSICIAN DEFLATED THE BALLOON AND REPOSITIONED IT WHILE THE GUIDEWIRE REMAINED IN PLACE. THE PHYSICIAN INFLATED THE LUTONIX DCB A SECOND TIME, BUT THE SAME AREA DID NOT INFLATE AND REPORTEDLY THE AREA OF THE BALLOON BEYOND THE STRICTURE WAS SLOW TO DEFLATE. REPORTEDLY, THE SECOND INFLATION WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635062 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED A LUTONIX 018 PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS ALLEGEDLY TWISTED AT THE DISTAL END WHILE TREATING THE TARGET LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS WITH A 6 FRENCH DESTINATION INTRODUCER SHEATH OVER AN 014 PHOENIX GUIDEWIRE. THE HCP PREPARED THE TARGET LESION WITH ATHERECTOMY. REPORTEDLY, THE HCP ADVANCED THE CATHETER TO THE TARGET LESION WITHOUT TWISTING THE CATHETER. ALLEGEDLY, AFTER INFLATION OF THE LUTONIX DCB, IT WAS TWISTED APPROXIMATELY 10 CM FROM THE DISTAL END OF THE BALLOON AT 8 ATMOSPHERES (ATMS). THE HCP MOVED THE BALLOON AFTER THE 2 MIN INFLATION PERIOD, AND THE TWISTED AREA DID NOT CHANGE. THE HCP REPORTEDLY REMOVED THE TWISTED LUTONIX DCB AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615448 ↗