Lutonix® Drug Coated Balloon BSCLX35130660Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741098499), received between Sep 9, 2015 and Mar 25, 2016 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionMar 25, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY HAD A MATERIAL RUPTURE. THE HEALTH CARE PROFESSIONAL (HCP) REPORTEDLY ADVANCED THE DCB TO THE TARGET LESION. UPON INFLATION OF THE LUTONIX DCB AT THE TARGET LESION, THE HCP REPORTEDLY REALIZED BLOOD WAS ACCUMULATING INSIDE THE INDEFLATOR. BASED ON THIS OBSERVATION, THE HCP BELIEVED THAT THE BALLOON HAD ALLEGEDLY "RIPPED". THE HCP REMOVED THE BALLOON SUCCESSFULLY FROM THE PATIENT AND USED ANOTHER LUTONIX DCB OF THE SAME SIZE TO EFFECTIVELY COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5525894 ↗
• InjurySep 9, 2015Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE TREATING THE COMMON FEMORAL ARTERY (CFA). THE TARGET LESION WAS THE RIGHT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA). THIS SFA LESION WAS FIRST TREATED BY LASER THROMBECTOMY FOLLOWED BY PREDILATION WITH A NORMAL PTA CATHETER. THE HCP PREPARED A LUTONIX DCB IN THE NORMAL FASHION. WHILE ADVANCING THE LUTONIX DCB TO THE SFA, THE HCP IDENTIFIED A DISEASE PORTION OF THE CFA, WHICH WAS NOT PREDILATED. THE DECISION WAS MADE TO TREAT THIS LOCATION FIRST, RATHER THAN PROCEEDING TO TREAT THE SFA LESION. THE HCP REPORTEDLY INFLATED THE LUTONIX DCB, IN THE COMMON FEMORAL ARTERY, TO 12 ATMOSPHERES AND AFTER 52 SECONDS OF TREATMENT THE BALLOON ALLEGEDLY RUPTURED. THE LUTONIX DCB WAS REMOVED WITHOUT DIFFICULTY. THE HCP PREPARED A SECOND LUTONIX DCB OF THE SAME SIZE AND ADVANCED THE CATHETER TO THE RIGHT OSTIAL SFA. THE HCP REPORTEDLY INFLATED THE SECOND LUTONIX DCB TO 10 ATMOSPHERES FOR 2 MINUTES. THE BALLOON SUCCESSFULLY TREATED THE RIGHT OSTIAL SFA AND WAS REMOVED. POST ANGIOGRAPHY REVEALED EVIDENCE OF A DISSECTION IN THE SFA LESION. THE DECISION WAS MADE TO STENT THE LESION I

  Patient problems: Intimal Dissection

  MAUDE report 5066025 ↗
• InjurySep 9, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE TREATING THE COMMON FEMORAL ARTERY (CFA). THE TARGET LESION WAS THE RIGHT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA). THIS SFA LESION WAS FIRST TREATED BY LASER THROMBECTOMY FOLLOWED BY PREDILATION WITH A NORMAL PTA CATHETER. THE HCP PREPARED A LUTONIX DCB IN THE NORMAL FASHION. WHILE ADVANCING THE LUTONIX DCB TO THE SFA, THE HCP IDENTIFIED A DISEASE PORTION OF THE CFA, WHICH WAS NOT PREDILATED. THE DECISION WAS MADE TO TREAT THIS LOCATION FIRST, RATHER THAN PROCEEDING THE SFA. THE HCP REPORTEDLY INFLATED THE LUTONIX DCB, IN THE COMMON FEMORAL ARTERY, TO 12 ATMOSPHERES AND AFTER 52 SECONDS OF TREATMENT THE BALLOON ALLEGEDLY RUPTURED. THE LUTONIX DCB WAS REMOVED WITHOUT DIFFICULTY. THE HCP PREPARED A SECOND LUTONIX DCB OF THE SAME SIZE AND ADVANCED THE CATHETER TO THE RIGHT OSTIAL SFA. THE HCP REPORTEDLY INFLATED THE SECOND LUTONIX DCB TO 10 ATMOSPHERES FOR 2 MINUTES. THE BALLOON SUCCESSFULLY TREATED THE RIGHT OSTIAL SFA AND WAS REMOVED. POST ANGIOGRAPHY REVEALED EVIDENCE OF A DISSECTION IN THE SFA LESION. AS A RESULT OF THE DISSECTION, THE HCP STENTED THE LESION I

  Patient problems: Intimal Dissection

  MAUDE report 5066023 ↗