Express® LD Iliac / Biliary H74938046940750Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392330), received between Nov 20, 2017 and Mar 5, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• MalfunctionMar 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLODGEMENT OCCURRED. A 9.0X40X75CM EXPRESS LD SENT BALLOON EXPANDABLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND IT WAS OBSERVED THAT THE STENT WAS NOT ATTACHED TO THE BALLOON CATHETER. THE DETACHED STENT WAS REPORTEDLY FOUND ON THE SCRUB TABLE WHILE THE TEAM WAS PREPARING. THE ISSUE WAS NOT PRESENT UPON OPENING THE PACKAGE. THE PROCEDURE WAS THEN COMPLETED USING 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 24519577 ↗
• InjuryMay 24, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT INSIDE THE PATIENT AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC. A 9.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION AND THEN BECAME DIFFICULT TO REMOVE FROM THE LESION. WHEN ATTEMPTED TO REMOVE THE DEVICE, THE STENT DISLODGED FROM THE BALLOON. AN ATTEMPT WAS MADE TO DEPLOY THE DISLODGED STENT WITH THE BALLOON BUT IT WAS UNSUCCESSFUL. THE BALLOON DELIVERY SYSTEM WAS REMOVED. A NON-BSC STENT WAS USED TO AFFIX AND APPOSE THE DISLODGED EXPRESS STENT TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492825 ↗
• MalfunctionMar 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA USER FACILITY MEDWATCH THAT STENT DISLODGEMENT OCCURRED. FOLLOWING PRE-DILATION, A 9.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION, THE STENT GOT DISLODGED. THE STENT WAS ABLE TO BE REPOSITIONED AND WAS SUCCESSFULLY IMPLANTED, COMPLETING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467353 ↗
• InjuryJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE MORE THAN 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERLY TORTUOUS LEFT COMMON AND EXTERNAL ILIAC ARTERIES. A 9.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF ITS BALLOON WHEN REMOVING THE STENT TO EXCHANGE GUIDEWIRES. THE BALLOON WAS REMOVED AND THE UNDEPLOYED STENT WAS SEEN IN THE SHEATH INSIDE THE BODY. THE PHYSICIAN USED A SMALL BALLOON AND INSERTED IT THROUGH THE UNDEPLOYED STENT WHICH WAS THEN SUBSEQUENTLY ADVANCED AND DEPLOYED SAFELY INTO THE EXTERNAL ILIAC ARTERY (EIA). AFTER STENT IMPLANTATION IN THE EIA, ANOTHER 9.0X40X75CM EXPRESS LD STENT WAS HANDED OFF TO TREAT THE LEFT COMMON ILIAC ARTERY. HOWEVER, IT WAS NOTICED THAT THE BALLOON IN WHICH THE STENT IS MOUNTED WAS WINGED OUT AT THE DISTAL PORTION. THE PHYSICIAN DECIDED NOT TO USED THE STENT AND FINISHED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 10345150 ↗
• MalfunctionNov 20, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. AFTER A 6FR INTRODUCER SHEATH WAS INSERTED, A 9.0X40X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DIFFICULTIES WERE ENCOUNTERED DURING INTRODUCTION OF THE DEVICE WHICH RESULTED TO THE DISTAL TIP OF THE STENT BECOMING FRAYED. THE PHYSICIAN DETERMINED THAT THE SHEATH WAS TOO SMALL AND SO IT WAS UPSIZED FROM 6FR TO 7FR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046199 ↗