LUTONIX® Drug Coated Balloon LX351005150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741088476), received between Sep 4, 2015 and Oct 23, 2017 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Torn Material” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2017Adverse 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE ON (B)(6) 2015, THE PATIENT¿S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. NO ADDITIONAL INTERVENTION WAS PERFORMED AT THAT TIME. ON (B)(6) 2017, APPROXIMATELY 30 MONTHS AFTER INDEX PROCEDURE, THE SITE REPORTED THAT THE SUBJECT UNDERWENT A REVASCULARIZATION PROCEDURE. THE REINTERVENTION INVOLVED A CORDIS SAVVY BALLOON, FOLLOWED BY TWO ABBOTT SUPERA STENTS. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT THE CEC HAS ADJUDICATED THE STUDY DEVICE TO BE POSSIBLY RELATED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00200.

  Patient problems: Reocclusion

  MAUDE report 6968304 ↗
• InjuryMar 10, 2017Adverse 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 SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL ARTERY. APPROXIMATELY 24 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND POPLITEAL VESSELS WERE REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED 4 MONTHS LATER AND THE HCP DEEMED IT WAS SUCCESSFUL. 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00044.

  Patient problems: Reocclusion

  MAUDE report 6397180 ↗
• InjuryMar 10, 2017Adverse 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 SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL ARTERY. APPROXIMATELY 24 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND POPLITEAL VESSELS WERE REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED 4 MONTHS LATER AND THE HCP DEEMED IT WAS SUCCESSFUL. 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00045.

  Patient problems: Reocclusion

  MAUDE report 6397115 ↗
• MalfunctionJan 18, 2017Torn Material; Torn Material

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY TORE DURING RETRACTION, AFTER TREATMENT OF A VERY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), MAKING IT DIFFICULT TO REMOVE. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO TREAT THE LEFT SFA. AFTER TREATMENT, THE HCP APPLIED NEGATIVE PRESSURE TO COMPLETELY DEFLATE THE BALLOON WHICH THE HCP VERIFIED UNDER FLUOROSCOPY. THE CATHETER WAS RETRACTED, BUT BECAME STUCK ABOUT THREE CENTIMETERS BEFORE THE END OF THE INTRODUCER SHEATH. THE HCP ATTEMPTED TO REMOVE THE CATHETER FOR APPROXIMATELY TEN MINUTES. IN THE END, THE HCP TORE THE CATHETER APART. THE PHYSICIAN REMOVED THE COMPLETE CATHETER FROM THE PATIENT. THE LUTONIX DCB WAS RETURNED FOR FURTHER EVALUATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6261096 ↗
• InjuryMar 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 CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. 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 3006513822-2016-00022.

  Patient problems: Reocclusion

  MAUDE report 5505317 ↗
• InjurySep 4, 2015Adverse Event Without Identified Device or Use Problem

  3006513822-2015-00031.

  Patient problems: Intimal Dissection; Reocclusion

  MAUDE report 5057328 ↗