LUTONIX® Drug Coated Balloon LX3513052205FRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741163418), received between Jul 10, 2024 and Feb 13, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON CATHETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331455 ↗
• MalfunctionJan 30, 2026Inflation Problem; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE LUTONIX 035 DRUG COATED BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219491 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRUG COATED BALLOON ANGIOPLASTY (DCB) PROCEDURE USING THE LUTONIX BALLOON CATHETER TO TREAT A LEFT FEMORAL ARTERY. DURING THE PROCEDURE CONTRAST AGENT LEAKAGE OCCURRED IN THE MID-SEGMENT OF THE BALLOON, PREVENTING FURTHER BALLOON EXPANSION. THE BALLOON AND SHEATH WERE RETRIEVED AS A SINGLE UNIT FROM THE BODY, AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. PREOPERATIVELY, THE OPERATOR REPORTED THE MAXIMUM BURST PRESSURE AS 12 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002466 ↗
• MalfunctionSep 8, 2025Inflation Problem; Material Deformation; Material Twisted/Bent; Inflation Problem; Material Deformation; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON (DCB) PTA CATHETER. DURING THE PROCEDURE, THE MIDDLE PART OF THE BALLOON WAS UNABLE TO INFLATE AND OPEN. IT WAS FURTHER REPORTED THAT A SEVERE CREASE WAS FOUND IN THE PART THAT COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992684 ↗
• MalfunctionMay 30, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE LUTONIX 035 DRUG COATED BALLOON (DCB) BALLOON CATHETER TO TREAT LEFT SUPERFICIAL FEMORAL ARTERY OCCLUSION VIA LEFT FEMORAL ARTERY. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY HAD A CONTRAST LEAKAGE WHEN EXPANDED AT 8 ATM. IT WAS FURTHER REPORTED THAT THERE WAS A SLIGHT RESISTANCE WHEN THE BALLOON WAS RECOVERED 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 22112656 ↗
• MalfunctionFeb 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY HAD A LEAKAGE. IT WAS FARTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311178 ↗
• MalfunctionOct 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE OCCLUDED LEFT FEMORAL ARTERY, THE DRUG-COATED BALLOON CATHETER WAS ALLEGEDLY RUPTURED AT 4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359451 ↗
• InjuryAug 21, 2024Inflation Problem; Difficult to Remove; Material Rupture; Material Twisted/Bent; Inflation Problem; Difficult to Remove; Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE AT 6 ATM. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED VESSEL TRAUMA AND DIFFICULTY IN RETRACTING THE BALLOON FROM THE SHEATH. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 20012458 ↗
• MalfunctionAug 14, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD A PINHOLE RUPTURE AT 6 ATM. IT WAS FURTHER REPORTED THAT THERE WAS AN DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980254 ↗
• MalfunctionJul 10, 2024Crack; Inflation Problem; Material Rupture; Crack; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DRUG-COATED BALLOON ALLEGEDLY COULD NOT BE OPENED WITH THE PRESSURE PUMP, AND WAS SUBSEQUENTLY WITHDRAWN FROM THE BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708576 ↗