Express® LD Iliac / Biliary H74938046720750Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729392194), received between Nov 1, 2018 and Dec 14, 2022 — classified as 3 malfunctions.

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

• MalfunctionDec 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. A 7.0X20X75CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED OVER WIRE. HOWEVER, DURING INTRODUCTION, THE STENT CAME OF THE BALLOON BEFORE REACHING THE LESION. THE STENT AND THE DELIVERY SYSTEM WERE REMOVED FROM THE BODY AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978982 ↗
• MalfunctionFeb 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGE OUTSIDE THE PATIENT. DURING PREPARATION OF A 7.0X20X75CM EXPRESS LD ILIAC / BILIARY STENT, IT WAS NOTICED THAT THE STENT WAS DETACHED FROM THE BALLOON. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545724 ↗
• MalfunctionNov 1, 2018Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN ILIAC VESSEL. A 7.0X20X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS ATTEMPTED TO BE REMOVED, THE DEVICE GOT CAUGHT IN THE CROSS CUT VALVE OF THE SHEATH AND THE STENT CAME OFF THE BALLOON OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8029285 ↗