LUTONIX® Drug Coated Balloon LX351305405FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741123191), received between Jun 18, 2017 and Oct 7, 2019 — classified as 4 injuries, 1 malfunction.

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

• InjuryOct 7, 2019Adverse 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE, THE PATIENT¿S LEFT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND IMAGING AND INTERVENTION WAS PERFORMED. IT WAS FURTHER REPORTED THAT DURING 36-MONTH FOLLOW-UP POST INDEX PROCEDURE, REOCCLUSION WAS IDENTIFIED VIA IMAGING AND INTERVENTION WAS PERFORMED.

  Patient problems: Reocclusion

  MAUDE report 9163684 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A (B)(6) CLINICAL STUDY 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 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO REVASCULARIZATION WAS PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES, BUT NOT RELATED TO THE INDEX PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR 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 3006513822-2019-00075.

  Patient problems: Reocclusion

  MAUDE report 8601467 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY 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 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND RIGHT ARTERY BELOW KNEE WERE REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. DURING THE VISIT TWO NEW ULCERS ON THE FOOT, SECOND AND FOURTH TOE, OF THE STUDY LIMB WERE REPORTEDLY DISCOVERED. A REVASCULARIZATION ON THE TARGET LESION INVOLVING A DCB AND RIGHT ARTERY BELOW THE KNEE INVOLVING POBA WAS PERFORMED. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED THE REVASCULARIZATION WAS SUCCESSFUL. SUBSEQUENTLY, ONE WEEK AFTER THE DISCOVERY OF THE FOOT ULCERS THE PATIENT UNDERWENT AN AMPUTATION OF THE FOURTH TOE AT METATARSOPHALANGEAL (MTP) JOINT. THE INVESTIGATOR ASSESSED THAT THE REOCCLUSION EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES, BUT THE NEW FOOT ULCERS THAT LED TO THE AMPUTATION WERE DEEMED NOT RELATED TO THE STUDY DEVICES. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER ADVERSE PATIENT

  Patient problems: Reocclusion

  MAUDE report 8324101 ↗
• MalfunctionMar 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS UNABLE TO INFLATE DUE TO A MATERIAL RUPTURE WHILE TREATING THE CALCIFIED TARGET LESION BETWEEN THE SUPERFICIAL FEMORAL ARTERY(SFA) AND THE TIBIO-PERONEAL TRUNK. THE HEALTH CARE PROFESSIONAL (HCP) USED AN IPSILATERAL APPROACH TO GAIN PATIENT ACCESS. THE HCP DID NOT PREDILATE THE CALCIFIED TARGET LESION. THE HCP BELIEVES THE CALCIFICATION OF THE TARGET LESION IS LIKELY RELATED TO THE NATURE OF THE MATERIAL RUPTURE. THE HCP USED ANOTHER DEVICE TO SUCCESSFULLY COMPLETE THE PATIENT'S PROCEDURE. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7310715 ↗
• InjuryJun 18, 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT POPLITEAL ARTERY. APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT 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 OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 6649337 ↗