Lutonix® Drug Coated Balloon BSCLX35130560Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741098451), received between Mar 17, 2016 and Jul 11, 2016 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT MAINTAIN PRESSURE WHILE TREATING THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) PREPARED THE TARGET LESION IN THE PROXIMAL POPLITEAL ARTERY WITH A JETSTREAM ATHERECTOMY DEVICE. THE HCP PREPARED THE LUTONIX DCB IN THE NORMAL FASHION AND REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES. THE LUTONIX DCB WAS ADVANCED UNDER NEGATIVE PRESSURE TO THE TARGET LESION. THE HCP INCREMENTALLY INFLATED THE BALLOON TO 4 ATMOSPHERES, BUT THE BALLOON ALLEGEDLY WOULD NOT MAINTAIN PRESSURE. THE HCP MANUALLY KEPT PRESSURE IN THE BALLOON FOR TWO MINUTES. THE HCP FELT THE TREATMENT WAS SUCCESSFUL. THE LUTONIX DCB WAS REMOVED AND THE PROCEDURE WAS COMPLETED AFTER ANOTHER LUTONIX DCB WAS USED TO TREAT A SECOND LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LUTONIX DCB WAS RETURNED FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5784093 ↗
• InjuryMar 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WITH AMPUTATION OF UNKNOWN EXTREMITY WERE PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, DRUG OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00039.

  Patient problems: Reocclusion

  MAUDE report 5508766 ↗
• InjuryMar 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WITH AMPUTATION OF UNKNOWN EXTREMITY WERE PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, DRUG OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00037.

  Patient problems: Reocclusion

  MAUDE report 5508601 ↗