LUTONIX® Drug Coated Balloon BSCLX351305150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741105012), received between Jan 6, 2016 and Mar 22, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 6 ATMOSPHERES (ATMS.) WHILE TREATING A HIGHLY CALCIFIED VESSEL IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS WITH A 7 FRENCH TERUMO DESTINATION INTRODUCER SHEATH. IT IS UNKNOWN IF THE HCP PREDILATED THE TARGET LESION. NO STENTS WERE NOTED TO BE PRESENT. THE HCP REPORTEDLY INFLATED THE LUTONIX DCB TO 6 ATMS AND THE BALLOON BURST. THE HCP SUCCESSFULLY REMOVED THE LUTONIX DCB AND USED A MUSTANG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON TO COMPLETE THE PROCEDURE. IN THE PHYSICIAN¿S OPINION, THE HIGHLY CALCIFIED LESION CAUSED THE MATERIAL RUPTURE. THE LUTONIX DCB WAS REQUESTED FOR RETURN TO COMPLETE AN EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6425557 ↗
• MalfunctionJan 6, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHEN TREATING THE EXTERNAL ILIAC ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED AN ATHERECTOMY OF THE EXTERNAL ILIAC ARTERY PRIOR TO TREATING THE TARGET LESION WITH THE LUTONIX DCB. THE HCP USED ANOTHER LUTONIX DCB TO COMPLETE THE PATIENT'S PROCEDURE. THE DISPOSITION OF THE SAMPLE IS UNKNOWN AT THIS TIME. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT ADDITIONAL INFORMATION IS UNAVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5348335 ↗