LUTONIX® Drug Coated Balloon LX35755605FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741122811), received between Feb 8, 2019 and Sep 23, 2019 — 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.

• InjurySep 23, 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT FEMORAL ARTERY. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT FEMORAL ARTERY WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Reocclusion

  MAUDE report 9106686 ↗
• 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 8324031 ↗