Express® LD Iliac / Biliary H74938047860130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729392484), received between Aug 6, 2019 and Sep 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY. AN 8.0X60X135 CM EXPRESS LD ILIAC / BILIARY STENT BALLOON EXPANDABLE WAS SELECTED FOR TREATMENT. DURING INTRODUCTION, IT WAS NOTED THAT THE DEVICE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158975 ↗
• MalfunctionMay 21, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30APR2024. IT WAS REPORTED THAT THE TIGHTLY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. AFTER IT WAS PRE-DILATED, AN 8.0 X 60 X 135CM EXPRESS LD ILIAC/ BILIARY STENT BALLOON WAS SELECTED TO PROCEED WITH THE TREATMENT. DURING THE PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE PHYSICIAN TRIED USING A STIFFER WIRE IN CASE THE STENT NEEDED ADDITIONAL SUPPORT, BUT THE DEVICE WOULD STILL NOT CROSS. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363394 ↗
• MalfunctionDec 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X60X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATEMENT. HOWEVER, IT WAS NOTED THAT A DEFECT WAS FOUND IN THE STENT STRUTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9521564 ↗
• MalfunctionAug 6, 2019Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-JUL-2019. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X60X135CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DEVICE FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT MOVED ON THE BALLOON AND STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865727 ↗