WallFlex™ M00547530Recalls & reported problems
Boston Scientific Corporation · Stent System · Class 2 · Implant
All models of WallFlex (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506044466), received between May 19, 2026 and Sep 3, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature Activation” (3 reports).
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
- Premature Activation3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599389 ↗MalfunctionMay 22, 2026Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026. DURING PREPARATION, PRIOR TO THE PROCEDURE, THE STENT WAS FOUND ALREADY DEPLOYED UPON OPENING THE PACKAGE. ANOTHER WALLFLEX BILIARY PLUS RX FULLY COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263129 ↗MalfunctionMay 19, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAN AN WALLFLEX BILIARY PLUS RX STENT SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT AREA TO PERFORM AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, PRIOR TO PLACING THE DEVICE OVER THE WIRE, THE PLASTIC PIECE WAS PULLED OUT OF THE CATHETER AND THE STENT PREMATURELY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX PLUS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225522 ↗
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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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