LUTONIX® Drug Coated Balloon LX3513061205FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741123290), received between Feb 9, 2017 and Sep 24, 2020 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LEGION IN SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10578845 ↗
• MalfunctionOct 24, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE PACKAGING WAS ALLEGEDLY NOT SEALED COMPLETELY. AFTER NOTICING THE ALLEGED INCOMPLETE SEAL, THE PACKAGE WAS OPENED ALL THE WAY IN PREPARATION FOR THE PROCEDURE. AFTER THE PHYSICIAN WAS ALERTED TO THE ALLEGED ISSUE, THE PHYSICIAN ELECTED TO NOT USE THE DEVICE AND REPORTEDLY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE OUTER BOX AND THE TAMPER PROOF SEAL WERE NOT DAMAGED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9235607 ↗
• InjuryMar 11, 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 LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION WAS NOT PERFORMED AT THIS TIME. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES AND 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 3006513822-2019-00043.

  Patient problems: Reocclusion

  MAUDE report 8408677 ↗
• InjuryApr 29, 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 CEPHALIC VENOUS OUTFLOW. DURING THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE TARGET LESION WAS REPORTEDLY PERFORATED. A REVASCULARIZATION WAS PERFORMED VIA PROLONGED BALLOONING AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE, TO THE PROCEDURE, AND 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: Perforation of Vessels

  MAUDE report 7471643 ↗
• InjuryApr 29, 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 CEPHALIC VENOUS OUTFLOW. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSEL CONTAINING THE 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 7471642 ↗
• MalfunctionNov 14, 2017Material Rupture; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY RUPTURED AT 10 ATMOSPHERES (ATMS) ON THE FIRST INFLATION WHILE TREATING THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) PREDILATED THE TARGET LESION PRIOR TO TREATING THE LOCATION WITH THE LUTONIX DCB. THE HCP USED AN ADDITIONAL DEVICE TO COMPLETE THE PROCEDURE. ALTHOUGH REQUESTED SEVERAL TIMES, ADDITIONAL INFORMATION REGARDING PATIENT DEMOGRAPHICS AND EVENT DETAILS WERE UNAVAILABLE. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION, BUT THE USER FACILITY HAS DISCARDED THE SAMPLE. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7031116 ↗
• MalfunctionMay 18, 2017Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, DURING PREPARATION, WAS ALLEGEDLY PUNCTURED WHILE REMOVING THE BALLOON PROTECTOR. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS USING A 6 FRENCH ANSEL INTRODUCER SHEATH AND A 260 COOK ROADRUNNER GUIDEWIRE. THE HCP LOADED THE LUTONIX DCB ONTO THE GUIDEWIRE WITHOUT REMOVING THE BALLOON PROTECTOR. REPORTEDLY, THE HCP DID NOT APPLY NEGATIVE PRESSURE TO THE BALLOON PRIOR TO OR DURING THE ATTEMPTED BALLOON PROTECTOR REMOVAL. ALLEGEDLY, THE SURGICAL TECH POSSIBLY DID NOT PINCH THE OPPOSITE SIDE OF THE BALLOON PROTECTOR WHEN PEELING. REPORTEDLY, THE HCP ADVANCED THE LUTONIX DCB TO THE INTRODUCER SHEATH HEMOSTASIS VALVE, AND THEN REMOVED THE BALLOON PROTECTOR, JUST PRIOR TO INSERTING THE DEVICE. REPORTEDLY, WHILE REMOVING THE BALLOON PROTECTOR THE BALLOON WAS UNKNOWINGLY DAMAGED. IN THE OPINION OF THE HCP, THE DAMAGE WAS A LONGITUDINAL PUNCTURE IN THE BALLOON AND NOT RELATED TO THE PATIENT'S ANATOMY. ALLEGEDLY, THE BALLOON WAS INSERTED INTO THE PATIENT AND SUCCESSFULLY ADVANCED TO THE TARGET LESION. REPORTEDLY, THE HCP PROCEEDED TO INFLATE THE BALLOON,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6576808 ↗
• InjuryFeb 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 CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 4 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 6314210 ↗