Express® LD Iliac / Biliary H74938047120130Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729392378), received between Apr 27, 2023 and Oct 14, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Failure to Deflate1
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.
MalfunctionOct 14, 2024Failure to Advance; Detachment of Device or Device Component; Device Dislodged or Dislocated; Failure to Advance; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT MOVED ON BALLOON AND TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 10.0X30X135 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. DURING INSERTION, CROSSING DIFFICULTIES WHILE TRACKING THE LESION WAS NOTED AND THE STENT PARTIALLY MOVED OFF BALLOON. ADDITIONALLY, THE DISTAL TIP OF THE STENT ON THE BALLOON BECAME PARTIALLY DETACHED. THE DEVICE WAS REMOVED COMPLETELY, 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 20439416 ↗DeathApr 27, 2023Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. THIS EXPRESS-B-I LD PMTED 10.0X30X135 CM WAS SELECTED FOR USE IN A PULMONARY PROCEDURE ON A CANINE. DURING THE PROCEDURE, ONCE THE STENT WAS EXPANDED, THE BALLOON WOULD NOT DEFLATE. IT WAS NOTED THE CANINE DID NOT RECOVER FROM THE PROCEDURE AND SUBSEQUENTLY PASSED AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16828587 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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