Express® LD Biliary H74938047540130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729484974), received between Apr 3, 2023 and Apr 3, 2023 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND REMOVAL DIFFICULTIES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X 40 X 135CM EXPRESS LD BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AS THE DEVICE WAS BEING MOVED INTO POSITION FOR DEPLOYMENT, RESISTANCE WAS FELT IN ADVANCING FORWARD. THE DEVICE WAS REMOVED WITH RESISTANCE ENCOUNTERED, IT WAS THEN NOTED THAT THE MID WAY SECTION OF THE STENT STRUT WAS PROTRUDING FROM THE CATHETER AND LOOKED DAMAGE. THE DEVICE WAS REMOVED INTACT THROUGH NORMAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AND FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665849 ↗