LUTONIX® Drug Coated Balloon LX181306605FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741177651), received between Oct 3, 2024 and Dec 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Adverse 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 THAT APPROXIMATELY TWO WEEKS POST AN INDEX PROCEDURE COMPLETION USING A DRUG-COATED BALLOON CATHETER FOR TARGET LESION STENOSIS ON THE LEFT UPPER ARM CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF LEFT FOREARM SWELLING AND FINGERTIP NUMBNESS AND NO PAIN. REPORTEDLY, THE ADVERSE EVENT DOESN'T MEET THE DEFINITION OF SERIOUS AND DOESN'T RESULT IN AV ACCESS CIRCUIT RE-INTERVENTION. THE ADVERSE EVENT RELATIONSHIP DETAILS WERE NOT PROVIDED. IT WAS FURTHER REPORTED THAT APPROXIMATELY NINE MONTHS AND TWO WEEKS POST AN INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF LEFT ARM AVF BLOCKAGE AND THROMBOSIS OF LEFT BRACHIOCEPHALIC AVF. REPORTEDLY, THE SUBJECT UNDERWENT OPEN LEFT CEPHALIC VEIN THROMBECTOMY PROCEDURE. THE ADVERSE EVENT RELATIONSHIP DETAILS WERE NOT PROVIDED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Numbness; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 23677654 ↗
• MalfunctionOct 3, 2024Failure to Advance; Device Markings/Labelling Problem; Failure to Advance; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A DRUG COATED BALLOON ANGIOPLASTY PROCEDURE, THE TWO CATHETERS ARE THE SAME EXACT SIZE BUT WERE ALLEGEDLY FOUND WITH TWO DIFFERENT CATHETER LENGTHS. IT WAS FURTHER REPORTED THAT THE SECOND BALLOON WAS A DIFFERENT LENGTH THAN THE FIRST AND WAS ALSO ALLEGEDLY NOT ABLE TO REACH THE LESION WHEN IT SHOULD HAVE BEEN. FURTHERMORE, IT WAS CONFIRMED THAT THE PRODUCT PACKAGING AND LABELS WERE CORRECT; HOWEVER, THE CATHETERS WERE ALLEGEDLY IN FACT DIFFERENT LENGTHS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20361389 ↗