WallFlex™ Biliary Transhepatic M00574780Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729820512), received between Aug 20, 2018 and Sep 1, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2023Premature Activation; Positioning Problem; Premature Activation; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED COMMON BILE DUCT TO DUODENUM. A 10MMX60MM WALLFLEX BILIARY STENT WAS DEPLOYED. HOWEVER, THE WALLFLEX STENT MOVED BACKWARDS WHEN THE PHYSICIAN TRIED TO WITHDRAW THE STENT CATHETER. THE PHYSICIAN THEN RECONSTRAINED THE STENT CATHETER WITHOUT ANY DIFFICULTY TO RECAPTURE THE NOSECONE, AND THE STENT MOVED FORWARD TO ITS ORIGINAL POSITION. FURTHERMORE, THE CATHETER WAS AGAIN WITHDRAWN, AND THE STENT MOVED BACKWARDS AND MISSED THE STRICTURE SITE. THE STENT WAS RECAPTURED AND WITHDRAWN SEVERAL TIMES UNTIL THE STENT DISLODGED FROM THE CATHETER. HENCE, ANOTHER 10X60MM WALLFLEX STENT WAS DEPLOYED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT IT WAS SUSPECTED THAT THE RETRIEVAL LOOP STUCK TO THE NOSE CONE. THEREFORE, WHEN THE CATHETER WAS WITHDRAWN AFTER EACH DEPLOYMENT, THE WHOLE SYSTEM MOVED TOGETHER. ADDITIONALLY, THE STENT WAS RECONSTRAINED SIX TIMES AND THE STENT PREMATURELY DEPLOYED. THERE WAS NO NOTICEABLE DAMAGE TO THE STENT OR THE DELIVERY CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673880 ↗
• MalfunctionFeb 27, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. THE PATIENT UNDERWENT BILIARY STENTING. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS VESSEL. A 10MM X 60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED FOR TREATMENT AND DEPLOYED THE STENT NORMALLY. HOWEVER, IT WAS NOTED THAT DISTAL PORTION OF THE STENT DID NOT FULLY DEPLOY, AND THE ENTIRE STENT CAME OUT WHEN THE PHYSICIAN PULLED THE DELIVERY CATHETER OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444172 ↗
• MalfunctionAug 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 10MMX60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE VALVE BODY AND EXTERIOR TUBE WERE SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE SHAFT SEPARATION OCCURRED 1 CM FROM THE HUB OUTSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10455453 ↗
• MalfunctionMay 15, 2019Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT HAD RECONSTRAINMENT ISSUES. THE TARGET LESION WAS LOCATED IN THE BILIARY VESSEL. A 10MM X 60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WOULD NOT DEPLOY CORRECTLY AND THE PHYSICIAN FELT THAT IT GOT CAUGHT UP ON OUTER SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT, BUT WAS REMOVED WITHOUT FULL RECONSTRAINMENT. THE STENT WAS EVENTUALLY DEPLOYED OUTSIDE 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 8611691 ↗
• MalfunctionSep 5, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND WAS REMOVED WITHOUT COMPLETE RE-CONSTRAINMENT. THE TARGET LOCATION WAS LOCATED IN THE BILIARY TRACT. A 10MMX60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS ADVANCED THROUGH A 9FR SHEATH AND DEPLOY TO THE DUODENUM WITH A WIRE. DURING REMOVAL OF DELIVERY SYSTEM FROM THE SHEATH, IT WAS NOTED THAT THE STENT WAS HALF DEPLOYED. THE ENTIRE SYSTEM WAS REMOVED THROUGH THE SHEATH AND PROCEDURE WAS COMPLETED WITH ANOTHER 10MMX60MM WALLFLEX BILIARY TRANSHEPATIC STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848054 ↗
• MalfunctionAug 20, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A 10MM X 60MM WALLFLEX BILIARY TRANSHEPATIC STENT WAS SELECTED FOR A PERCUTANEOUS BILIARY STENT PROCEDURE. DURING THE PROCEDURE, THE STENT BECAME HUNG UP ON THE DELIVERY SYSTEM AND DELIVERY SHEATH. THE STENT WOULD NOT COME OFF. THE PHYSICIAN REMOVED THE WHOLE SYSTEM AND USED ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING GREAT POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799140 ↗