LUTONIX® Drug Coated Balloon LX3513061005FRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741123283), received between Nov 3, 2016 and Jun 15, 2022 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE EXPIRY DATE IN THE LABEL ALLEGEDLY MISMATCHED WITH THE DATE IN JDE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694043 ↗
• MalfunctionApr 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DRUG-COATED BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT ANOTHER DRUG-COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913775 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 22 DAYS POST INDEX PROCEDURE, CORE LAB ANALYSIS WAS PERFORMED AND IDENTIFIED REOCCLUSION OF THE TARGET LESION IN THE PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS FURTHER REPORTED THAT A REVASCULARIZATION, INVOLVING A VASCULAR BYPASS WAS PERFORMED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE OUTCOME WAS RESOLVED AND RECOVERED.

  Patient problems: Reocclusion

  MAUDE report 8754975 ↗
• MalfunctionMay 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE BEING INFLATED TO 12 ATMOSPHERES (ATMS) IN THE HIGHLY CALCIFIED TARGET LESION OF THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) USED A RETROGRADE APPROACH THROUGH THE RIGHT COMMON FEMORAL ARTERY WITH A 6 FRENCH INTRODUCER SHEATH (BRAND UNKNOWN) OVER AN 018 GUIDEWIRE (BRAND UNKNOWN). REPORTEDLY, THE HCP PREPARED THE CALCIFIED TARGET LESION WITH ATHERECTOMY FOLLOWED BY A SCORING BALLOON FOR PRE-DILATATION. THE HCP REMOVED THE BALLOON PROTECTOR WITHOUT ISSUES, BUT IT IS UNKNOWN IF NEGATIVE PRESSURE WAS APPLIED DURING ADVANCEMENT TO THE TARGET LESION. ALLEGEDLY, THE HCP INFLATED THE LUTONIX DCB TO 12 ATMS FOR A MINUTE AND A HALF WHEN REPORTEDLY IT RUPTURED, A PINHOLE RUPTURE. IN THE OPINION OF THE HCP, HE DEFINITELY BELIEVES THE BALLOON RUPTURED DUE TO THE HIGHLY CALCIFIED LESION. THE LUTONIX DCB WAS DISCARDED BY USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579368 ↗
• MalfunctionApr 3, 2019Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED WHILE TREATING THE CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) BEFORE REACHING NOMINAL PRESSURE. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN ACCESS TO THE TARGET LESION WITH A BENTSON GUIDEWIRE. IT IS UNKNOWN IF THE HCP PREDILATED THE TARGET LESION. THE HCP INFLATED THE LUTONIX DCB TO 4 ATMOSPHERES (ATMS) WHEN THE HCP NOTICED THE BALLOON WAS NOT INFLATED. IN THE OPINION OF THE HCP, THE CALCIFIED ANATOMY OF THE TARGET LESION IS POSSIBLY RELATED TO THE NATURE OF THE RUPTURE. REPORTEDLY, THERE ARE NO STENTS PRESENT IN THE TARGET LESION OR TRACKING PATH. THE HCP USED ANOTHER DEVICE TO COMPLETE THE PATIENT'S PROCEDURE. THE LUTONIX DCB WAS RETURNED FOR EVALUATION. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478418 ↗
• InjuryMar 5, 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 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO REVASCULARIZATION WAS NOT PERFORMED AT THIS TIME. 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 3006513822-2019-00038.

  Patient problems: Reocclusion

  MAUDE report 8392702 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED BETWEEN 2-3 ATMOSPHERES (ATMS)WHILE ATTEMPTING TO TREAT THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HEALTH CARE PROFESSIONAL (HCP) GAINED PATIENT ACCESS THROUGH AN IPSLATERAL APPROACH WITH A 6 FRENCH COOK RABI INTRODUCER SHEATH. THE TARGET LESION WAS PREPARED THROUGH ATHERECTOMY PRIOR TO THE USE OF THE LUTONIX DCB. ONCE THE HCP REACHED THE TARGET LESION, THE BALLOON WAS REPORTEDLY INFLATED AND RUPTURED PRIOR TO REACHING NOMINAL PRESSURE. REPORTEDLY, THE TRACKING PATHWAY TO THE TARGET LESION WAS NOT TORTUOUS AND NO PREVIOUSLY PLACED STENTS WERE PRESENT. THE HCP SUCCESSFULLY REMOVED THE LUTONIX DCB AND COMPLETED THE PATIENT'S PROCEDURE WITH A NON DRUG COATED BALLOON. IN THE OPINION OF THE HCP, THE ANATOMY WAS NOT RELATED TO THE NATURE OF THE MATERIAL RUPTURE. 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 7675931 ↗
• InjuryApr 9, 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 LESIONS LOCATED IN THE LEFT CEPHALIC VEIN. APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESIONS WERE 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 7406563 ↗
• InjuryFeb 26, 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 REINTERVENTION PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 MONTHS AFTER THE REINTERVENTION 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 7295814 ↗
• InjuryNov 15, 2017Retraction Problem; Material Rupture; Torn Material; Retraction Problem; Material Rupture; Torn Material

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 12 ATMOSPHERES (ATMS) WHILE TREATING A NON CALCIFIED RIGHT COMMON FEMORAL ARTERY (CFA). THE HEALTH CARE PROFESSIONAL (HCP) USED A 5 FRENCH COOK ANSEL INTRODUCER SHEATH OVER AN 035 WILLIE GUIDEWIRE TO GAIN PATIENT ACCESS. ALLEGEDLY, THE HCP DID NOT PREDILATE THE TARGET LESION, BUT WAS ABLE TO ADVANCE THE LUTONIX DCB TO THE TARGET LESION WITHOUT ISSUES. REPORTEDLY, THE HCP INFLATED THE LUTONIX DCB TO 12 ATMS AND THE BALLOON RUPTURED DURING THE TREATMENT. UPON RETRACTION OF THE LUTONIX DCB, THE DISTAL TIP OF THE BALLOON BECAME DETACHED INSIDE THE PATIENT'S VASCULATURE. IT WAS FURTHER REPORTED MULTIPLE ATTEMPTS BY THE HEALTH CARE PROVIDER WERE MADE TO RETRIEVE THE CATHETER TIP USING A SNARE DEVICE. THE HCP WAS UNSUCCESSFUL. THE HEALTH CARE PROVIDER DECIDED TO LEAVE THE DETACHED CATHETER TIP IN SITU, AS THERE WAS NO POTENTIAL HEALTH HAZARD TO THE PATIENT. THE PROCEDURE WAS CONCLUDED, AND ALTHOUGH REQUESTED, IT IS UNKNOWN IF FURTHER TREATMENT WAS PERFORMED. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION, BUT THE USER FACILITY WILL NOT RELEASE THE SAMPLE TO

  Patient problems: Foreign Body In Patient

  MAUDE report 7033354 ↗
• 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT MID SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING ANOTHER MANUFACTURERS DEVICE AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION: IT WAS REPORTED THAT APPROXIMATELY 35 MONTHS POST PROCEDURE, PATIENT DEVELOPED OCCLUSION AT THE TARGET LESION AND REVASCULARIZATION WAS PERFORMED.

  Patient problems: Reocclusion

  MAUDE report 6554060 ↗
• MalfunctionNov 3, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT THREE ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE HEALTH CARE PROFESSIONAL (HCP) USED A BRACHIAL APPROACH TO TREAT THE COMMON FEMORAL ARTERY(CFA). THE HCP APPLIED NEGATIVE PRESSURE DURING ADVANCEMENT TO THE TARGET LESION. THE TARGET LESION WAS HEAVILY CALCIFIED. IN THE HCP'S OPINION, THE HEAVILY CALCIFIED LESION CONTRIBUTED TO THE RUPTURING OF THE BALLOON AT THREE ATMS DURING LESION TREATMENT. THE LUTONIX DCB WAS REMOVED SUCCESSFULLY, AND REPORTEDLY, ANOTHER DRUG COATED BALLOON PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE LUTONIX DCB WAS RETURNED FOR FURTHER EVALUATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6075589 ↗