Lutonix® Drug Coated Balloon LX35100580Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741088353), received between Mar 16, 2016 and Sep 9, 2016 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT SIX ATMOSPHERES IN THE DISTAL POPLITEAL ARTERY. REPORTEDLY, THE CATHETER WAS REMOVED AND IT APPEARED THAT THE MATERIAL RUPTURE WAS CIRCUMFERENTIAL. DIAGNOSTIC IMAGING WAS PERFORMED, WHICH REVEALED THE DISTAL HALF OF THE BALLOON WAS STILL IN THE PATIENT. THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED A CUTDOWN TO THE POPLITEAL ARTERY TO RETRIEVE THE DISTAL PORTION OF THE BALLOON. THE HCP SUCCESSFULLY RETRIEVED ALL OF THE BALLOON REMNANTS FROM THE PATIENT'S VESSEL. THE PATIENT RECOVERED FROM THE PROCEDURE AND THE SURGICAL CUTDOWN. THE LUTONIX DCB WAS RETURNED FOR FURTHER EVALUATION. IMAGES OF THE LUTONIX DCB WERE ALSO OBTAINED FOR REVIEW. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 5939222 ↗
• InjuryMar 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO THE INDEX PROCEDURE, ALLEGEDLY THE PATIENT HAD A PURULENT NAIL BED INFLAMMATION AND PERIUNGUAL NECROSIS OF THE FIRST TOE LEFT SIDE AT THE TIME OF ENROLLMENT AND THE INDEX PROCEDURE. TREATMENT WITH ANTIBIOTICS, TAVANIC, WAS STARTED DURING THE INDEX PROCEDURE ADMISSION. THE PATIENT WAS THEN TREATED WITH THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER. REPORTEDLY, A FEW MONTHS LATER THE PATIENT'S FIRST TOE LEFT SIDE OF THE TARGET LIMB BECAME INFLAMED FROM THE PRE-EXISTING INFECTED SKIN ULCER. THE PATIENT WAS HOSPITALIZED AND REPORTEDLY AN AMPUTATION WAS PERFORMED DUE TO PROGRESSIVE GANGRENE OF THE LEFT FOREFOOT. THE CEC ADJUDICATED THE EVENT AS POSSIBLY 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00058 AND 3006513822-2016-00059.

  Patient problems: Gangrene

  MAUDE report 5510641 ↗
• 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 CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT 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 3006513822-2016-00021.

  Patient problems: Reocclusion

  MAUDE report 5505448 ↗