Express® SD Renal/Biliary H74937912419900Recalls & reported problems
Boston Scientific Corporation · Premounted Stent System · Class 3
All models of Express SD Renal/Biliary (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729390466), received between Jun 17, 2021 and Jun 17, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RENAL ARTERY. A 4.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS DETACHED FROM THE BALLOON. THE DEVICE WAS REMOVED BY PULLING IT OUT ON THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12017435 ↗
Other STENT, RENAL devices
- Herculink Elite 1011487-15Abbott Vascular Inc. · STENT, RENAL27 reports
- Express® SD Renal/Biliary H74937912618150Boston Scientific Corporation · STENT, RENAL27 reports
- Herculink Elite 1011487-12Abbott Vascular Inc. · STENT, RENAL24 reports
- Herculink Elite 1011493-18Abbott Vascular Inc. · STENT, RENAL1 death16 reports
- Herculink Elite 1011499-18Abbott Vascular Inc. · STENT, RENAL13 reports
- Herculink Elite 1011487-18Abbott Vascular Inc. · STENT, RENAL13 reports
- Herculink Elite 1011499-15Abbott Vascular Inc. · STENT, RENAL12 reports
- Herculink Elite 1011493-12Abbott Vascular Inc. · STENT, RENAL11 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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