Express® LD Iliac / Biliary H74938046640750Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729392156), received between Dec 14, 2017 and Oct 29, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 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 THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL MESENTERIC ARTERY. A 6.0X40X75CM EXPRESS LD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS PLACED OVER A GUIDEWIRE, BUT THE PHYSICIAN OBSERVED THAT THE STENT WAS TOO LONG FOR THE LESION. WHILE REMOVING THE STENT SYSTEM, UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE STENT WAS COMING OFF THE BALLOON. THE PHYSICIAN IMMEDIATELY STOPPED, THEN ADVANCED THE SYSTEM FORWARD TO RETRIEVE THE STENT AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THE STENT DID NOT COMPLETELY DISLODGE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414458 ↗
• InjurySep 28, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON AND SNARING OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NOT TORTUOUS SUPERIOR MESENTERIC ARTERY OSTIUM. A6.0X40X75CM EXPRESS LD ILIAC / BILIARY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE SHAFT FRACTURED. THE DEVICE WAS REMOVED BY SNARING, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840001 ↗
• InjuryAug 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED REQUIRING INTERVENTION. A 6.0 X 40 X 75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE PREVIOUSLY STENTED SUPERIOR MESENTERIC ARTERY. HOWEVER, DURING THE PROCEDURE, THE STENT CAME LOOSE ON THE BALLOON AND CAME OFF OF THE CATHETER SHAFT. THE LESION WAS REWIRED AND THE LOOSE STENT WAS ENTRAPPED WITH A NON-BOSTON SCIENTIFIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552166 ↗
• InjuryJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED RESULTING TO AN ADDITIONAL INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY WITH A 6X45 NON-BOSTON SCIENTIFIC (BSC) SHEATH. THE 75-90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 6.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS INSERTED OVER A .014 WIRE, THE SHAFT LENGTH WAS DETERMINED TO BE NOT LONG ENOUGH TO DEPLOY THE STENT. THE DEVICE WAS ATTEMPTED TO BE REMOVED; HOWEVER, UPON TRYING TO PULL IT BACK INTO THE SHEATH, THE UNINFLATED STENT PULLED OFF OF THE UNINFLATED BALLOON, AND WAS SITTING ON THE 0.14 NOT EXPANDED WIRE. THE 6X45 SHEATH WAS REPLACED WITH A 7X45 NON-BSC SHEATH. SUBSEQUENTLY, A 10X40 EPIC STENT WAS USED TO TRAPPED AND CRUSHED THE EXPRESS LD STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095500 ↗
• InjuryMay 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE CONTRALATERAL APPROACH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED INTERNAL ILIAC ARTERY. A 6.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS DISLODGED INSIDE THE PATIENT. ANOTHER GUIDEWIRE AND MULTIPLE OTHER DEVICES WERE USED TO ATTEMPT RETRIEVAL, BUT FAILED. FINALLY, THE STENT WAS INFLATED IN PLACE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11834890 ↗
• MalfunctionNov 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED VIA MEDWATCH MW5097294. A 6.0 X 40 X 75CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE BALLOON MOVED FORWARD ON THE SHAFT OF THE BALLOON BEFORE IT COULD DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875869 ↗
• InjuryDec 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 6.0X40X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO GET CONTROL OF THE STENT AND BALLOONED IT OPEN WITH ANOTHER BALLOON. THE STENT WAS IMPLANTED IN THE TARGET LESION AND WAS ABLE TO COMPLETE THE PROCEDURE USING THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116659 ↗