Express® LD Iliac / Biliary H74938046860750Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392293), received between Feb 21, 2019 and Dec 21, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2025Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2025. IT WAS REPORTED THAT STENT WAS DIFFICULT TO INSERT. AN 8.0X60X75CM EXPRESS LD STENT WAS SELECTED FOR USE IN AN ILIAC STENTING PROCEDURE. DURING THE PROCEDURE, STENT WAS PREPARED ACCORDING TO STANDARD PROCEDURE BUT COULD NOT BE INTRODUCED INTO THE NON-BOSTON SCIENTIFIC SHEATH. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIRST TWO ROWS OF THE PROXIMAL STENT STRUTS WERE FOUND TO BE LIFTED/DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861096 ↗
• MalfunctionNov 13, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RETROGRADE APPROACH. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILD TO MODERATELY CALCIFIED EXTERNAL ILIAC ARTERY. A 7F SHEATH AND 0.35 NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE WAS ADVANCED, AND THE DISEASED LESION WAS DETERMINED USING A NON-BSC IVUS CATHETER THROUGH COMMON AND EXTERNAL ILIAC ARTERY. AN 8.0X60X75CM EXPRESS LD ILIAC/BILIARY STENT BALLOON EXPANDABLE CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, RESISTANCE WAS FELT WHEN THE STENT WAS ADVANCED INTO COMMON ILIAC WITH POSSIBLE PLAQUE. THE STENT WAS REMOVED, AND THE LESION WAS DILATED WITH A 6MM BALLOON CATHETER. THE STENT WAS REINSERTED AGAIN, BUT STILL WOULD NOT ADVANCE. THE PHYSICIAN PLACED A 7MMX80 NON-BSC STENT IN THE EXTERNAL ILIAC, AND POST-DILATED WITH 6MM BALLOON. THE PHYSICIAN REINSERTED THIS STENT AGAIN, BUT STILL WOULD NOT ADVANCE. THIS STENT WAS REMOVED AND SUSPECTED THAT THE PROXIMAL END WAS DAMAGE BUT COULD NOT CONFIRM. A NEW 7X45 SHEATH WAS PLACED IN THE COMMON ILIAC AND TRIED AGAIN TO REINSERT THIS EXPRESS LD STENT INTO THE SHEATH, BUT IT WAS DIFFICULT TO ADVANCE THROUGH THE HUB. THE PHYSICIAN INSPECTED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675098 ↗
• MalfunctionMay 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE STENOSED TARGET LOCATION WAS LOCATED IN THE ILIAC ARTERY. AN 8.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION AND PRIOR TO INSERTION, THE STENT APPEARED TO BE FLARED ON THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234524 ↗
• MalfunctionAug 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MODERATELY CALCIFIED ON RIGHT, AND SEVERELY CALCIFIED ON LEFT BILATERAL COMMON ILIAC ARTERIES. A 8.0X60X75CM EXPRESS LD ILIAC/BILIARY STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT DISMOUNTED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306459 ↗
• MalfunctionFeb 21, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT UNSEALED DEVICE PACKING WAS ENCOUNTERED. DURING PREPARATION OF A 8.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT, IT WAS NOTED THAT THE INNER POUCH WAS NOT COMPLETELY SEALED. THERE WAS NO VISIBLE HOLE OR TEAR IN THE POUCH. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8358514 ↗