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Express® LD Iliac / Biliary H74938047940130Recalls & reported problems

Boston Scientific Corporation · Premounted Stent System · Class 3

All models of Express LD Iliac / Biliary (34)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729392507), received between Jun 7, 2024 and Jan 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1
  • Difficult to Remove1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 8, 2026Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT A SMALL HOLE IN THE PACKAGING OCCURRED. A 9.0X40X135 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. UPON OPENING THE DEVICE, A SMALL HOLE WAS NOTICED IN THE OUTER PACKAGING, WHICH COMPROMISED THE STERILITY OF THE STENT. 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 24004887 ↗
  • MalfunctionJun 7, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X40X135CM EXPRESS LD STENT WAS ADVANCE FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT GOT STUCK IN THE LESION, SO IT WAS DECIDED TO WITHDRAW THE STENT AND TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA) AGAIN. HOWEVER, WHEN TRYING TO WITHDRAW THE STENT INTO THE 7FR SHEATH, IT COULD NOT BE RETRACTED INTO THE SHEATH, AND THE STENT HAD SEPARATED FROM THE BALLOON. SINCE THE STENT COULD NOT BE RETRACTED, IT HAD TO BE RELEASED IN THE EXTERNAL ILIAC ARTERY. THE STENT WAS NOT IMPLANTED AT THE WANTED LOCATION, BUT IT FULLY COVERED THE LESION. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19489176 ↗

Other STENT, ILIAC devices

All STENT, ILIAC devices →

Sources and updates

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