WallFlex™ Biliary M00570630Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729759270), received between Mar 29, 2019 and Jan 13, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS USED TO TREAT A BILE LEAKAGE AFTER AN ABDOMINAL TUMOR SURGERY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DUODENAL PAPILLA WAS INCISED AFTER ENTERING THE ENDOSCOPE. THE STENT WAS NOT SUCCESSFULLY PLACED AFTER ENTERING THE COMMON BILE DUCT ALONG THE GUIDEWIRE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145882 ↗
• InjuryDec 19, 2024Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED TO TREAT A BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6). 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THE STENT WAS FOUND TO BE BROKEN. THE STENT WAS REMOVED USING A SNARE, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20979207 ↗
• InjuryMay 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A 6MM CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE RECONSTRAINED BEFORE THE MARKER REACHED THE NON-RETURN POINT. SUBSEQUENTLY, THE STENT WAS DEPLOYED AND WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19365078 ↗
• InjuryNov 22, 2021Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 01, 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT AN 80MM LESION OBSTRUCTING THE COMMON BILE DUCT SECONDARY TO PANCREATIC CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE OUTER SHEATH BROKE AND INNER SHEATH DETACHED DURING ATTEMPTED DEPLOYMENT. THE PHYSICIAN PUSHED OUT THE DETACHED INNER SHEATH FROM THE SCOPE USING ANOTHER CATHETER INTO THE PATIENT AND REMOVED THE INNER SHEATH USING FORCEPS. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852135 ↗
• MalfunctionMar 29, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 7, 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT HAS BEEN IMPLANTED IN THE INTRAHEPTIC DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. REPORTEDLY, THE PHYSICIAN CUT THE DELIVERY SYSTEM AND LEFT A SMALL PORTION OF THE INNER SHAFT INSIDE THE PATIENT. THE PHYSICIAN WAS CLINICALLY COMFORTABLE LEAVING THE INNER SHAFT INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8466292 ↗