WallFlex™ Biliary Transhepatic M00574630Recalls & reported problems
Boston Scientific Corporation · Stent System · Class 2
Data updated Oct 16, 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 08714729799412), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- Material Integrity Problem1
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 5, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A WALLFLEX BILIARY STENT WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE STENT WAS DAMAGED, AND THE DELIVERY SYSTEM WAS DAMAGED. THE PRODUCT WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22152509 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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