WallFlex™ Biliary Transhepatic M00574730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729799344), received between Feb 27, 2019 and Dec 16, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILE DUCT. A 10MMX60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT WAS PLACED AND THE DELIVERY SYSTEM WAS REMOVED, RESISTANCE WAS FELT ON THE STENT AND DELIVERY AND THE STENT JUMPED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THAT STENT MIGRATED FROM THE TARGET LOCATION AFTER RELEASE. THE STENT REMAINED IMPLANTED AND AN ADDITIONAL STENT WAS IMPLANTED TO COVER THE LESION. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 11020138 ↗
• MalfunctionFeb 21, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. A 10MMX60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE SIZE OF THE STENT WAS TOO HARD TO DETERMINE BASED ON SHORTENING. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739730 ↗
• MalfunctionFeb 27, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN A BILE DUCT ARTERY. A 10MMX60MM WALLFLEX BILIARY TRANSHEPATIC STENTS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE GUIDEWIRE GOT STUCK INSIDE THE STENT DELIVERY SYSTEM. A NON-BSC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374431 ↗