WallFlex™ Biliary M00570700Recalls & reported problems
Boston Scientific Corporation · Stent System · Class 2 · Implant
All models of WallFlex Biliary (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729759294), received between Sep 28, 2021 and Jun 18, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Obstruction/Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Migration; Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED IN THE DUODENUM AND COMMON BILE DUCT (CBD) TO TREAT A MALIGNANT OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024. ON (B)(6) 2025, IT WAS FOUND THAT THE STENT DISTALLY MIGRATED OUT OF THE CBD INTO THE STOMACH. THIS WAS NOTICED AS THE PATIENT PASSAGEWAY BECAME OBSTRUCTED, BUT NO SPECIFIC SYMPTOMS WERE REPORTED. THE STENT WAS RETRIEVED AND REMOVED FROM THE PATIENT BY PERFORMING AN ESOPHAGOGASTRODUODENOSCOPY COMBINED WITH AN ERCP, AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED. THE PATIENT ENDURE AN ENDOSCOPIC PROCEDURE TO RETRIEVE AND IMPLANT A NEW STENT.
Patient problems: Obstruction/Occlusion
MAUDE report 22284901 ↗MalfunctionSep 28, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM GOT CAUGHT WITHIN THE STENT AND IT WAS DIFFICULT TO REMOVE. THE WALLFLEX BILIARY STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12544084 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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