LUTONIX® Drug Coated Balloon BSCLX351306150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741105029), received between Nov 20, 2015 and Jul 17, 2017 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2017Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE. DURING THE REMOVAL THE BALLOON, IT BECAME STUCK, RESULTING IN THE BALLOON ALLEGEDLY RUPTURING AND COMING APART. THE HEALTH CARE PROFESSIONAL (HCP) USED A ROTABLATOR ATHERECTOMY DEVICE TO PREPARE THE HEAVILY CALCIFIED VESSEL FOR LUTONIX DCB TREATMENT. THE HCP REPORTEDLY INFLATED THE LUTONIX DCB TO SUCCESSFULLY TREAT THE TARGET LESION, BUT AFTERWARDS IT ALLEGEDLY BECAME STUCK. THE BALLOON ALLEGEDLY RUPTURED. THE HCP HAD TO TAKE A COUPLE EXTRA STEPS TO REMOVE THE BALLOON, BUT NO ADDITIONAL COMPLICATIONS WERE NOTED. THE HCP SUCCESSFULLY REMOVED THE DEVICE FROM THE PATIENT. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6716835 ↗
• MalfunctionMay 2, 2017Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WOULD NOT INFLATE AT THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) REMOVED THE LUTONIX DCB FROM THE PATIENT AND ATTEMPTED TO INFLATE IT. AS THE HCP TRIED TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT, REPORTEDLY THERE WAS A HOLE IN THE BALLOON BECAUSE IT WOULD NOT FILL WITH FLUID. THE HCP USED ANOTHER LUTONIX DCB OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538006 ↗
• InjuryFeb 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER TREATMENT WITH TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, ALLEGEDLY AN EMBOLIZATION OCCURRED AT DISTAL END OF THE TARGET LESION. THE TARGET LESION AND VESSEL MORPHOLOGY REVEALED 80-90% SEGMENTAL OCCLUSION WITH TWO DISTINCT AREAS WHICH WERE MOST SIGNIFICANT. THE HEALTH CARE PROFESSIONAL (HCP) GAINED ACCESS TO THE LEFT FEMORAL ARTERY AND PERFORMED AN ARTHRECTOMY PROCEEDED BY PREDILATION WITH A SCORING PTA CATHETER. THE HCP TREATED THE TARGET LESION WITH TWO LUTONIX DCB'S. DURING THE PROCEDURE POST DCB TREATMENT, THE HCP REVIEWED THE ANGIOGRAPHY, WHICH REVEALED A GOOD RESULT WITHIN THE TARGET LESION. HOWEVER, THERE WAS ALMOST NO FLOW TO THE DISTAL VESSELS SUGGESTING AN EMBOLIZATION. THE HCP PROCEEDED TO TREAT THE EMBOLIZATION BY REMOVING THE FILTER FILLED WITH THROMBOGENIC MATERIAL AND USING ANGIOJET THROMBECTOMY WITH MULTIPLE PASSES WITH A 4 AND 5 FRENCH SIZES. AFTER TREATMENT, ANGIOGRAPHY REVEALED THERE WAS A FOCAL OCCLUSION DISTAL TO THE TARGET LESION. ADDITIONAL BALLOONING ATTEMPTS WERE PERFORMED BY THE HCP, WHICH INCREASED FLOW DISTALLY, BUT THE RESISTANT CLOT STILL REMAINED. THE PATIENT WAS PLACED ON A REGIMENT OF

  Patient problems: Embolus

  MAUDE report 5457568 ↗
• InjuryFeb 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER TREATMENT WITH TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, ALLEGEDLY AN EMBOLIZATION OCCURRED AT DISTAL END OF THE TARGET LESION. THE TARGET LESION AND VESSEL MORPHOLOGY REVEALED 80-90% SEGMENTAL OCCLUSION WITH TWO DISTINCT AREAS WHICH WERE MOST SIGNIFICANT. THE HEALTH CARE PROFESSIONAL (HCP) GAINED ACCESS TO THE LEFT FEMORAL ARTERY AND PERFORMED AN ATHERECTOMY PROCEEDED BY PREDILATION WITH A SCORING PTA CATHETER. THE HCP TREATED THE TARGET LESION WITH TWO LUTONIX DCB'S. DURING THE PROCEDURE POST DCB TREATMENT, THE HCP REVIEWED THE ANGIOGRAPHY, WHICH REVEALED A GOOD RESULT WITHIN THE TARGET LESION. HOWEVER, THERE WAS ALMOST NO FLOW TO THE DISTAL VESSELS SUGGESTING AN EMBOLIZATION. THE HCP PROCEEDED TO TREAT THE EMBOLIZATION BY REMOVING THE FILTER FILLED WITH THROMBOGENIC MATERIAL AND USING ANGIOJET THROMBECTOMY WITH MULTIPLE PASSES WITH A 4 AND 5 FRENCH SIZES. AFTER TREATMENT, ANGIOGRAPHY REVEALED THERE WAS A FOCAL OCCLUSION DISTAL TO THE TARGET LESION. ADDITIONAL BALLOONING ATTEMPTS WERE PERFORMED BY THE HCP, WHICH INCREASED FLOW DISTALLY, BUT THE RESISTANT CLOT STILL REMAINED. THE PATIENT WAS PLACED ON A REGIMENT OF

  Patient problems: Embolus

  MAUDE report 5457384 ↗
• MalfunctionNov 20, 2015Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AFTER BEING INFLATED FOR 15 SECONDS. THE LUTONIX DCB WAS REMOVED COMPLETELY AND WITHOUT DIFFICULTY. THE HEALTH CARE PROFESSIONAL (HCP) COMPLETED THE PROCEDURE WITH A NORMAL PTA BALLOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5240600 ↗