WALLSTENT™ RX BILIARY M00569810Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729456728), received between Nov 10, 2017 and Dec 10, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT RX BILIARY UNCOVERED STENT WAS USED TO TREAT AN APPROXIMATELY 6CM MALIGNANT HILAR STRICTURE DUE TO CHOLANGIO CARCINOMA DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON NOVEMBER 13, 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT WIRE OF THE STENT WAS COMING OUT OF THE SHEATH, WHICH RESULTED IN DEPLOYMENT FAILURE. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898990 ↗
• MalfunctionAug 8, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLSTENT BILIARY STENT COULD NOT BE FULLY DEPLOYED. THE WALLSTENT BILIARY STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE STENT WIRES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188677 ↗
• MalfunctionJul 19, 2021Break; Material Deformation; Activation Failure; Break; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS IMPLANTED TO TREAT A 7-CM MALIGNANT STRICTURE IN THE LOWER COMMON BILE DUCT (CBD) DURING BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY UNDER FLUOROSCOPY. HOWEVER, THE PHYSICIAN NOTED THAT THE DISTAL END OF THE STENT DID NOT FULLY EXPAND. ADDITIONALLY, IT WAS NOTED THAT THE STENT WIRES WERE KINKED AND BROKEN AT THE PROXIMAL END OF THE STENT. THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED. 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. HOWEVER, THE PHYSICIAN WILL CONTINUE TO FOLLOW UP TO CONFIRM THERE ARE NOT ANY ISSUES DUE TO THE DAMAGED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188654 ↗
• MalfunctionJul 13, 2021Entrapment of Device; Mechanical Problem; Premature Activation; Material Deformation; Entrapment of Device; Mechanical Problem; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT BILE DUCT CANCER DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED WITHIN THE RECONSTRAINABILITY LIMIT. THE PHYSICIAN ATTEMPTED TO READJUST THE STENT BUT IT WAS UNABLE TO RECONSTRAIN. THE DEVICE WAS REMOVED AND ANOTHER WALLSTENT BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THE STENT WAS DAMAGED. ADDITIONAL INFORMATION RECEIVED ON JULY 1, 2021 AND JULY 12, 2021: WHILE REMOVING THE STENT, IT GOT STUCK WITHIN THE WORKING CHANNEL OF THE SCOPE AND HENCE GOT KINKED, DAMAGED AND DEPLOYED DURING THE RETRIEVAL PROCESS. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158424 ↗
• MalfunctionFeb 9, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A HILAR CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO FULLY DEPLOY INSIDE THE PATIENT. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO RE-CONSTRAIN THE STENT. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER WALLSTENT BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PHYSICIAN FULLY DEPLOYED THE STENT OUTSIDE OF THE PATIENT. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300432 ↗
• InjuryApr 27, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 4, 2018 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE HILAR REGION OF THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON APRIL 4, 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT, THE STAINLESS STEEL TUBE SUDDENLY TWISTED, AND CAUSING 80-90% OF THE STENT TO BE DEPLOYED OUTSIDE THE PAPILLA. THE STENT WAS REMOVED FROM THE PAPILLA WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. 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 Consequences Or Impact To Patient

  MAUDE report 7468735 ↗
• MalfunctionNov 10, 2017Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 21, 2017 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A STRICTURE BELOW THE HILUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ¿NOT RELEASED¿ AND REMAINED COLLAPSED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER WALLSTENT BILIARY RX UNCOVERED STENT. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7020958 ↗