WallFlex™ Biliary Transhepatic M00574740Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729799375), received between Apr 20, 2023 and Apr 20, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION AND WAS REMOVED. A WALLFLEX BILIARY TRANSHEPATIC STENT WAS SELECTED FOR USE TO TREAT PANCREATIC HEAD CONDITIONAL OBSTRUCTIVE JAUNDICE. PERCUTANEOUS ACCESS WAS ACHIEVED VIA A PERIPHERAL BILE DUCT OF THE FIFTH SEGMENT. THE WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED TO COVER A SECTION OF BILIARY STENOSIS. HOWEVER, THE STENT POSITION WAS NOT OPTIMAL AS IT COVERED A BILE DUCT. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RECAPTURE THE STENT USING THE DISTAL LOOP, HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED AND HAD FOLDED UPON ITSELF. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS USED TO RE-OPEN THE STENT. AN EXTERNAL-INTERNAL BILIAGE DRAINAGE WAS PLACED THROUGH WHICH THE STENT WAS REMOVED. A NEW STENT WAS PLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776263 ↗