Express® LD Iliac / Biliary H74938047820130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729392460), received between Jun 28, 2022 and Mar 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• MalfunctionMar 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VESSEL. AN 8.0X20X135 CM EXPRESS LD AC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO INSERTING INTO THE BODY, IT WAS NOTED THAT THE STENT LOOKED KINKED ON THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892910 ↗
• MalfunctionOct 16, 2023Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 8.0X20X135 CM EXPRESS LD STENT WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE BALLOON WAS ALREADY EXPANDED WHEN UNWRAPPING THE PACKAGE. THE DEVICE WAS NOT USED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939061 ↗
• InjuryJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AND THE PATIENT WAS SENT TO SURGERY. THE TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. A 8.0X20X135 CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DISLODGED AND THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842813 ↗