Express® LD Iliac / Biliary H74938047740130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729392446), received between Feb 27, 2017 and Oct 21, 2025 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 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 MOVED ON BALLOON OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 7.0X40X135 CM EXPRESS LD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS INSERTED THROUGH A BSC 11CM 6F SHEATH. IT WAS NOTED THAT THE STENT COULD NOT CROSS THE TIGHT LESION. THE STENT WAS REMOVED. THE ARTERY WAS PRE-DILATED WITH A BSC .035 BALLOON 5X40 SUCCESSFULLY. THE LD STENT WAS REINSERTED THROUGH THE SHEATH AND CROSSED LESION. HOWEVER, ONCE THE STENT WAS POSITION ACROSS THE LESION, IT WAS NOTED THAT THE STENT WAS HALFWAY SLIDE BACK ON THE ITS BALLOON. THE SHEATH WAS REMOVED AND THE LD STENT CATHETER WAS REMOVED FROM THE BODY FULLY INTACT WITH BALLOON AND STENT 100% AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347886 ↗
• MalfunctionAug 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT CAME LOOSE FROM THE BALLOON. A 7.0X40X135 CM EXPRESS LD BALLOON STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT STENT CAME LOOSE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804982 ↗
• MalfunctionSep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 65-75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTERY. A 7.0X40X135 CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ADVANCING SYSTEM OUT OF THE SHEATH, IT WAS NOTICED THAT THE STENT WAS MIGRATED OFF FROM THE BALLOON. THE DEVICE WAS REMOVED BY PULLING BACK THE ENTIRE SYSTEM WITH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A 7X37 NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508205 ↗
• InjuryNov 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE OCCLUDED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 7.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON AND IT WAS UNABLE TO BE REMOVED. THE DISLODGED STENT WAS DEPLOYED AND ANOTHER OF THE SAME DEVICE WAS DEPLOYED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305805 ↗
• MalfunctionMar 23, 2017Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 07-MAR-2017. IT WAS REPORTED THAT CATHETER TRACKING DIFFICULTIES OVER THE GUIDE WIRE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY (SMA). AFTER A GUIDE WIRE CROSSED THE LESION, A 7.0X40X135 CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED HOWEVER, THE DEVICE WOULD NOT PASS OVER THE WIRE. IT KEPT HANGING UP ON THE SAME SPOT ON THE WIRE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE WIRE AND ANOTHER 7.0X40X135 CM EXPRESS® LD ILIAC / BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT MOVEMENT ON BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429557 ↗
• MalfunctionFeb 27, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT INADEQUATE APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0X40X135 CM EXPRESS® LD ILIAC / BILIARY STENT WAS IMPLANTED TO TREAT THE LESION. HOWEVER, THE STENT WAS NOT WELL APPOSED. THE PHYSICIAN REMOVED THE DEVICE ACCORDING TO THE STANDARD METHOD WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6360290 ↗