WallFlex™ Biliary Transhepatic M00574720Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729799368), received between May 20, 2026 and May 20, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

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.

• InjuryMay 20, 2026Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT INTERVENTION WAS REQUIRED. THE PATIENT PRESENTED WITH A LARGE PANCREATIC TUMOR WITH A TORTUOUS, TIGHTLY STENOSED BILIARY TREE. A 10MMX40MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS SELECTED FOR TREATMENT VIA TRANS BILIARY APPROACH. DURING THE PROCEDURE, THE LESION WAS NOT PRE-DILATED AND DIFFICULTY CROSSING THE LESION WAS NOTED. DURING STENT DEPLOYMENT, DIFFICULTY WAS NOTED AND THE STENT DEPLOYED WITH LESS THAN 1CM OUT OF THE SHEATH, AND THE MAJORITY OF THE STENT REMAINING WITHIN THE SHEATH. THE STENT WAS RECAPTURED, AND BOTH THE SHEATH AND DELIVERY SYSTEM WERE REMOVED AS A SYSTEM. THE PATIENT WAS MOVED TO GASTROENTEROLOGY (GI) TO ATTEMPT STENT PLACEMENT; HOWEVER, THIS WAS UNSUCCESSFUL, AND THE PROCEDURE WAS PROLONGED. THE PROCEDURE WAS SUBSEQUENTLY CANCELLED, AND A DRAINAGE CATHETER WAS PLACED FOR PALLIATIVE PURPOSES AND THE PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236187 ↗