Express® LD Iliac / Biliary H74938046820750Recalls & 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 08714729392255), received between Feb 8, 2019 and Mar 1, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-FEB-2019. AN 8.0X20X75CM EXPRESS LD ILIAC/BILIARY STENT WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DISPLACED STENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8382390 ↗MalfunctionFeb 8, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN 8.0X20X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE BALLOON RUPTURED. THE STENT WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH POST-DILATION OF A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8320928 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page