WallFlex™ Biliary Transhepatic M00574710Recalls & reported problems
Boston Scientific Corporation · Stent System · Class 2 · Implant
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 08714729799399), received between Sep 25, 2025 and Sep 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
- Material Integrity Problem1
- Nonstandard Device1
- Positioning Failure1
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.
MalfunctionSep 25, 2025Positioning Failure; Nonstandard Device; Material Integrity Problem; Activation Failure; Positioning Failure; Nonstandard Device; Material Integrity Problem; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. THE TARGET LESION WAS LOCATED IN THE BILE DUCT. AN 8MMX80MM WALLFLEX BILIARY TRANSHEPATIC SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. HOWEVER, STRONG RESISTANCE WAS ENCOUNTERED AND IT COULD NOT BE MOVED MIDWAY AT THE START OF DEPLOYMENT, PREVENTING THE STENT FROM BEING RELEASED. THE STENT WAS FULLY RECAPTURED UPON REMOVAL, AND ALTHOUGH THE STENT WAS RELEASED OUTSIDE THE BODY, THE FLARED TIP SECTION COULD NOT BE RE-RETRACTED AND PROTRUDED FROM THE SHEATH TIP. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PHYSICIAN BELIEVED THAT THE DAMAGE OCCURRED TO THE DELIVERY TIP WHEN PASSING THROUGH A SECTION OF THE BILE DUCT EXHIBITING SIGNIFICANT CURVATURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23148813 ↗
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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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