LUTONIX® Drug Coated Balloon LX351004150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741088469), received between Oct 27, 2015 and Jul 23, 2018 — classified as 5 injuries.

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 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT PROXIMAL POPLITEAL ARTERY. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED 14 MONTHS AFTER THE INDEX PROCEDURE USING ONLY ARMADA PTA BALLOONS AND THE PLACEMENT OF SMARTFLEX STENTS. THE HCP DEEMED THE REVASCULARIZATION WAS SUCCESSFUL. TWO MONTHS LATER, 16 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S TARGET LESION WAS REPORTEDLY REOCCLUDED FOR A SECOND INSTANCE. THE PATIENT UNDERWENT A SUBSEQUENT REVASCULARIZATION PROCEDURE, 27 MONTHS AFTER THE INDEX PROCEDURE, WITH A MEDTRONIC IMPACT ADMIRAL BALLOON WHICH WAS DEEMED SUCCESSFUL BY THE HCP. THE INVESTIGATOR ASSESSED THAT THE SECOND EVENT OF REOCCLUSION WAS NOT RELATED TO THE LUTONIX STUDY DEVICES OR INDEX PROCEDURE, BUT THE CEC ADJUDICATED THE SECOND REOCCLUSION EVENT AS POSSIBLY RELATED TO THE LUTONIX STUDY DEVICES. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT A

  Patient problems: Reocclusion

  MAUDE report 7710230 ↗
• InjuryJul 16, 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 CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND THE RIGHT PROXIMAL POPLITEAL ARTERY. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT DISTAL SFA VESSEL HAD REPORTEDLY WORSENED IN THE RIGHT LIMB. AFTER DUPLEX ULTRASOUND AT 12 MONTHS, THE HCP DETERMINED THE TARGET LESION HAD REOCCLUDED. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. ON (B)(6), THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE WORSENING SYMPTOMS. THE HCP PERFORMED A REVASCULARIZATION OF THE TARGET LESION IN THE RIGHT DISTAL SFA AND PROXIMAL POPLITEAL ARTERY. THE PROCEDURE WAS SUCCESSFUL AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBERS IS 3006513822-2016-00145.

  Patient problems: Reocclusion

  MAUDE report 5800829 ↗
• InjuryApr 22, 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 RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 8 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED USING NORMAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH STENT PLACEMENT WHICH THE HCP DEEMED SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE 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 3006513822-2016-00099.

  Patient problems: Reocclusion

  MAUDE report 5599771 ↗
• InjuryMar 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SUCCESSFUL PROCEDURE IN (B)(6) 2014. INFORMATION WAS PROVIDED FROM THE CUSTOMER THAT FOUR MONTHS POST INDEX PROCEDURE THE PATIENT DEVELOPED REOCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY IN THE TARGET LIMB. A NEW ANGIOGRAM WAS COMPLETED ON (B)(6) 2015. THE TARGET LIMB WAS ASSESSED TO HAVE 95% STENOSIS. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS COMPLETED ON (B)(6) 2015 WITH AN ABBOTT ARMADA 4X40MM BALLOON. THERE WAS 0% RESIDUAL STENOSIS POST-REVASCULARIZATION. THE RE-VASCULARIZATION WAS SAID TO BE SUCCESSFUL. THE PATIENT HAS A HISTORY OF CHRONIC RENAL INSUFFICIENCY, LIVER CIRRHOSIS, HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, IS A CURRENT SMOKER, AND A FAMILY HISTORY OF PERIPHERAL VASCULAR DISEASE, CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE. SUBJECT'S RELEVANT POST-PROCEDURE CONCOMITANT MEDICATIONS INCLUDE LIPID MODIFYING AGENTS, THROMBOSIS 100MG (ASPIRIN), PLAVIX 75MG. THE SUBJECT WAS ALSO ON THESE MEDICATIONS AT THE 1 MONTH FOLLOWUP VISIT. NO PATIENT INJURY WAS INITIALLY REPORTED.

  Patient problems: Reocclusion

  MAUDE report 5511604 ↗
• InjuryOct 27, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE THE PHYSICIAN USED TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS TO TREAT THE TARGET LESION LOCATED FROM THE MIDDLE ONE-THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL ARTERY OF THE RIGHT LEG. APPROXIMATELY 8 MONTHS LATER, THE HCP WAS UNABLE TO OBTAIN PATIENT ACCESS TO THE REOCCLUDED RIGHT SFA THROUGH THE COMMON FEMORAL ARTERY DUE TO THE HIGH DEGREE OF CALCIFICATION. THEREFORE, A PERIPHERAL VASCULAR BYPASS SURGERY WAS PERFORMED FROM THE COMMON FEMORAL TO THE POPLITEAL ARTERY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2015-00047.

  Patient problems: Reocclusion

  MAUDE report 5181493 ↗