Lutonix® Drug Coated Balloon LX35100460Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741088308), received between Jul 16, 2016 and Jul 23, 2018 — classified as 2 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 2 most recent of 2 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 7710215 ↗
• 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 3006513822-2016-00144.

  Patient problems: Reocclusion

  MAUDE report 5800832 ↗