WALLSTENT™ RX BILIARY M00569620Recalls & reported problems
Boston Scientific Corporation · RX Biliary Endoprosthesis Stent System · Class 2 · Implant
All models of WALLSTENT RX BILIARY (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729296829), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2024Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, RESISTANCE WAS FELT DURING DELIVERY AND THE PATIENT EXPERIENCED PAIN. THE DEVICE WAS THEN REMOVED, AND IT WAS NOTED THAT THE STENT WIRE PUNCTURED THE TIP PART OF THE OUTER SHEATH CAUSING INJURY TO THE PATIENT'S BILIARY VESSEL. THE PATIENT WAS ADMINISTERED WITH PAINKILLERS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A BENIGN STENOSIS. HOWEVER, PER THE WALLSTENT RX BILIARY, WITH OR WITHOUT PERMALUME COVERING INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE IN THE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS. THE DEVICE IS NOT INDICATED FOR THE TREATMENT OF BENIGN STENOSIS. PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED SHOWING THE STENT'S WIRE PUNCTURED THE OUT
Patient problems: Insufficient Information; Pain
MAUDE report 19153620 ↗
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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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