Express® LD Iliac / Biliary H74938047720130Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392439), received between May 4, 2018 and Dec 4, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS SELECTED FOR USE IN A LEG ANGIOGRAM. DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF BALLOON. ANOTHER 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS USED, HOWEVER SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720233 ↗
• MalfunctionDec 4, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS SELECTED FOR USE IN A LEG ANGIOGRAM. DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF BALLOON. ANOTHER 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS USED, HOWEVER SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720231 ↗
• MalfunctionAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CELIAC VESSEL. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION, A GUIDE CATHETER WAS THEN USED FOR SELECTIVE IMAGING. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED AND INSERTED OVER THE WIRE. HOWEVER, THE STENT CAME OFF THE BALLOON SHAFT AND WAS STUCK IN TUOHY AS THE TUOHY WAS NOT OPENED UP ENOUGH. FURTHERMORE, ONCE THE STENT WAS SEEN DETACHED INSIDE THE TUOHY, THE SHEATH AND THE TUOHY WERE ALL REMOVED, AND THE WIRE REMAINED. A NEW 6F SHEATH AND GUIDE CATHETER WERE USED, AND ANOTHER 7X20X135 EXPRESS LD STENT WAS DEPLOYED PERFECTLY AND ACCURATELY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624509 ↗
• InjuryMay 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VESSEL. AFTER PLACING A 7F GUIDE CATHETER OSTIUM OF ILIAC, A 7.0X20X135 CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED THROUGH THE GUIDE CATHETER FORCIBLY. HOWEVER, UPON PULLING THE DEVICE BACK, THE STENT SHEARED OFF FROM THE BALLOON INTO THE ABDOMINAL AORTA. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE STENT AND FINALLY WAS ABLE TO SNARE THE STENT OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A 8F GUIDE CATHETER AND A DIFFERENT STENT WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513849 ↗
• MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. THE VERY TIGHT STENOSIS WAS LOCATED IN THE OSTIAL SUPERIOR MESENTERIC ARTERY. A 7.0X20X135 CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AS THE STENT WAS ADVANCED, IT WAS NOTED THAT THE STENT SLIDE OFF. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7487014 ↗