WallFlex™ Biliary Transhepatic M00574690Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729799351), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Markings/Labelling 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.

• InjuryJul 8, 2022Device Markings/Labelling Problem; Migration; Device Markings/Labelling Problem; Migration

  IT WAS REPORTED THAT A COVERED STENT, LABELED AS AN UNCOVERED STENT, WAS IMPLANTED AND PARTIALLY MIGRATED. A WALLFLEX TRANSHEPATIC UC 10MMX100MM SELF-EXPANDING STENT WAS USED IN A BILIARY STENT PROCEDURE, FOR DUODENAL STENOSIS. THE STENT WAS IMPLANTED AND THE PROCEDURE ENDED SUCCESSFULLY. THREE DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN/COMPLICATIONS. AN UPPER GASTROINTESTINAL ENDOSCOPY WAS PERFORMED. THE STENOSIS AND THE BILIARY STENT WERE EASILY PASSED WITH A THERAPEUTIC GASTROSCOPE. THE BILIARY STENT WAS SEEN, PARTIALLY MIGRATED, BUT STILL LARGELY WITHIN THE BILIARY TREE. THE PHYSICIAN ELECTED NOT TO PLACE A DUODENAL STENT. THE PATIENT WOULD BE UPGRADED TO A SOFT DIET AND AIM FOR DISCHARGE. ADDITIONALLY, IT WAS NOTED THAT WHEN THE UNCOVERED STENT WAS VIEWED ENDOSCOPICALLY, IT APPEARED TO BE A COVERED STENT. FURTHER INFORMATION WAS REPORTED INDICATING THAT THE PATIENT NEEDED A SECOND INTERVENTION. AT THAT TIME NO RETRIEVAL HOOK WAS FOUND. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 14961440 ↗