LUTONIX® Drug Coated Balloon LX35757605FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741122934), received between Nov 10, 2017 and Jul 13, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryJul 13, 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT VIABAHN INTRASTENT GRAFT. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESION 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, BUT DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. 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 7686863 ↗
• MalfunctionJan 12, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED, AFTER A SUCCESSFUL TREATMENT, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO RETRACT AND BECAME STUCK IN THE INTRODUCER SHEATH. THE HEALTH CARE PROFESSIONAL (HCP) INFLATED THE LUTONIX DCB SUCCESSFULLY TO TREAT THE TARGET LESION. AS THE HCP WAS REMOVING THE LUTONIX DCB, IT BECAME STUCK WITHIN THE INTRODUCER SHEATH. IT IS UNKNOWN IF THE BALLOON WAS COMPLETELY DEFLATED UNDER FLUOROSCOPY OR OF IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON. THE HCP REMOVED THE LUTONIX DCB AND THE INTRODUCER SHEATH AS A SINGLE UNIT WHILE MAINTAINING PATIENT ACCESS WITH THE GUIDEWIRE. AN ADDITIONAL INTRODUCER SHEATH WAS PLACED AND THE HCP COMPLETED THE PROCEDURE SUCCESSFULLY. THE LUTONIX DCB HAS BEEN RETURNED. DURING THE PRELIMINARY EVALUATION, IT WAS DISCOVERED THAT THE SAMPLE HAD A SMALL LONGITUDINAL MATERIAL RUPTURE. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185549 ↗
• InjuryNov 10, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED, AFTER SUCCESSFUL TREATMENT OF THE TARGET LESION, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY BECAME STUCK IN THE INTRODUCER SHEATH DURING RETRACTION OF THE DEVICE. THE HEALTH CARE PROFESSIONAL (HCP) USED AN IPSILATERAL APPROACH WITH A 5F TERUMO INTRODUCER SHEATH OVER AN 035 TERUMO GUIDEWIRE. THE HCP TREATED THE TARGET LESION WITHOUT DIFFICULTY. AFTER TREATMENT, THE HCP DEFLATED THE LUTONIX DCB COMPLETELY AND VERIFIED THE DEFLATED BALLOON UNDER FLUOROSCOPY. NEGATIVE PRESSURE WAS APPLIED TO THE LUTONIX DCB AND THE HCP ATTEMPTED TO RETRACT THE DEVICE. THE BALLOON PORTION OF THE CATHETER BECAME STUCK IN THE INTRODUCER SHEATH. THE HCP REAPPLIED NEGATIVE PRESSURE SEVERAL TIMES, BUT THE CATHETER REMAINED STUCK. THE HCP SURGICALLY INTERVENED TO RETRIEVE THE BALLOON FROM THE PATIENT. THE ORIGINAL ACCESS TO THE PATIENT WAS MAINTAINED. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7016835 ↗