LUTONIX® Drug Coated Balloon LX351306805FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741126888), received between May 9, 2017 and Mar 28, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2023Infusion or Flow Problem

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND PERIPHERAL VASCULAR DISEASE IN THE RIGHT LOWER EXTREMITY. WHILE HAVING A RIGHT LOWER EXTREMITY ANGIOGRAM/ANGIOPLASTY, THE WIRE OF THE LUTONIX 035 WOULD NOT PASS THROUGH THE BALLOON. DEVICE REMOVED WITHOUT KNOWN HARM TO THE PATIENT, DISCHARGE THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627221 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT THREE MONTHS AND TWENTY-NINE DAYS POST INDEX PROCEDURE USING DRUG COATED BALLOON, THE SUBJECT HAD ADVERSE EVENT RECURRENT STENOSIS OF TARGET LESION IN CEPHALIC VEIN WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION. IT WAS FURTHER REPORTED THAT FIVE MONTHS AND SIX DAYS POST INDEX PROCEDURE, THE TARGET LESION HAD MAXIMUM INITIAL STENOSIS OF NINETY PERCENT. TWO NUMBER OF LUTONIX DRUG COATED BALLOON DEVICES WERE USED FOR TREATMENT. THE RE-INTERVENTION WAS SUCCESSFUL, AND THE PATIENT RECOVERED WITH FIFTEEN PERCENT RESIDUAL STENOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 16231660 ↗
• MalfunctionAug 5, 2021Material Rupture; Device Damaged Prior to Use; Material Rupture; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO THE ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY HAD A HOLE WHEN IT WAS OPENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278997 ↗
• InjurySep 17, 2018Adverse 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 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED. IT IS UNKNOWN AT THIS TIME, IF A REVASCULARIZATION WAS PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES, BUT NOT RELATED TO THE 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 3006513822-2018-00195.

  Patient problems: Reocclusion

  MAUDE report 7880780 ↗
• MalfunctionMay 25, 2018Difficult to Remove; Torn Material; Difficult to Remove; Torn Material

  IT WAS REPORTED, AFTER SUCCESSFUL TREATMENT OF THE NON CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY WAS UNABLE TO BE REMOVED THROUGH THE 5 FRENCH COOK ANSEL INTRODUCER SHEATH. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS WITH 5 FRENCH COOK ANSEL INTRODUCER SHEATH. REPORTEDLY, AFTER TREATING THE TARGET LESION, THE HCP COMPLETELY DEFLATED THE LUTONIX DCB AND VERIFIED THE COMPLETELY DEFLATED BALLOON UNDER FLUOROSCOPY. THE HCP STILL WAS UNABLE TO RETRACT THE LUTONIX DCB THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE HCP REMOVED THE LUTONIX DCB AND THE INTRODUCER SHEATH SIMULTANEOUSLY. IT IS UNKNOWN IF NEGATIVE PRESSURE WAS CONTINUALLY APPLIED DURING THE RETRACTION ATTEMPT. DURING THE RETRACTION ATTEMPT, THE LUTONIX DCB SEPARATED INTO MULTIPLE PIECES. THE ENTIRE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL SURGICAL INTERVENTION. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544571 ↗
• InjuryApr 3, 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 A REVASCULARIZATION PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 19 MONTHS AFTER THE REVASCULARIZATION PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE 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 SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER ARE 3006513822-2018-00076 AND 3006513822-2018-00077.

  Patient problems: Reocclusion

  MAUDE report 7394095 ↗
• InjuryOct 27, 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 LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00225.

  Patient problems: Reocclusion

  MAUDE report 6983600 ↗
• InjuryMay 9, 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 PROXIMAL MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROXIMAL MID SFA VESSEL, WHICH WAS STENTED AFTER A DISSECTION DURING THE INDEX PROCEDURE, 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00085.

  Patient problems: Reocclusion

  MAUDE report 6554248 ↗