WALLSTENT™ BILIARY H965430500Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729204671), received between Dec 21, 2016 and Jul 21, 2025 — classified as 4 injuries, 9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Positioning Failure; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE COULD NOT BE DEPLOYED. THE STENT REMAINED FULLY COVERED BY THE OUTER SHEATH UPON REMOVAL, AND NO PARTIAL DEPLOYMENT WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS STABLE AT THE CONCLUSION OF THE PROCEDURE. NOTE: IT WAS REPORTED THAT THE SHIPPING MANDREL WAS MANUALLY REMOVED PRIOR TO ADVANCING THE GUIDEWIRE THROUGH THE DEVICE. PER THE IFU, "BY INSERTING THE TRAILING END OF THE GUIDEWIRE, THE SHIPPING MANDREL WILL BE PUSHED OUT. DO NOT REMOVE THE SHIPPING MANDREL BEFORE LOADING THE GUIDEWIRE." NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF INNER SHEATH DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560345 ↗
• MalfunctionJan 10, 2024Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 6CM BILE DUCT MALIGNANT STENOSIS DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE TIP WAS KINKED, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE TIP WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM AND ANOTHER WALLSTENT BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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 18484868 ↗
• MalfunctionOct 16, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS USED TO TREAT A MALIGNANT BILIARY OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GUIDEWIRE WAS LOADED AND STENT DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED SHOWING THE STENT WIRES FROM THE PARTIALLY DEPLOYED STENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939255 ↗
• MalfunctionAug 12, 2022Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED IN THE BILIARY DUCT TO TREAT A MALIGNANT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLSTENT BILIARY STENT WOULD NOT DEPLOY. THE WALLSTENT BILIARY STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY DEVICE. 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 RESULTS WHICH REVEALED THAT THE TWO STENT WIRES PUNCTURED THE OUTER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15221088 ↗
• MalfunctionJul 14, 2021Positioning Failure; Material Puncture/Hole; Failure to Advance; Positioning Failure; Material Puncture/Hole; Failure to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 4CM BILIARY STRICTURE DUE TO GALLBLADDER CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE TIGHT STRICTURE. THE STENT WIRE PUNCTURED THE OUTER SHEATH AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168028 ↗
• InjuryOct 1, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) , 2020 THAT A WALLSTENT BILIARY UNCOVERED STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY. THE STENT WAS INSPECTED AFTER PLACEMENT VIA ENDOSCOPIC IMAGING AND THE PHYSICIAN NOTED THAT THE STENT WIRES WERE BROKEN. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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. A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT OF THE IMPLANTED STENT IN THE PATIENT AND IT SHOWS THAT THE STENT WIRES WERE DAMAGED. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020*** ACCORDING TO THE COMPLAINANT, A PLASTIC STENT WAS IMPLANTED INSIDE THE WALLSTENT BILIARY UNCOVERED STENT TO CORRECT THE BROKEN STENT AND THE PROCEDURE WAS COMPLETED. REPORTEDLY, THE PATIENT WILL BE BROUGHT IN FOR A FOLLOW-UP TO CHECK WHETHER THE STENT HAS CAUSED ANY DAMAGE OR ULCER TO THE DUODENUM WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617086 ↗
• MalfunctionMar 24, 2020Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED IN A MALIGNANT COMMON BILE DUCT STRICTURE DURING A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED WHEN THE PHYSICIAN VISUALIZED ON FLUOROSCOPY THAT A STENT WIRE HAD DETACHED FROM THE STENT. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9875376 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY UNCOVERED STENT HAD BEEN IMPLANTED TO TREAT A PERIAMPULLARY MALIGNANT STRICTURE IN THE MID COMMON BILE DUCT DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. ON (B)(6) 2019, ACCORDING TO THE COMPLAINANT, THE PATIENT DEVELOPED CHOLANGITIS POST PROCEDURE. THE STENT REMAINS IMPLANTED. NO INFORMATION HAS BEEN RECEIVED REGARDING THE CAUSE OF THE CHOLANGITIS, HOW IT WAS TREATED OR RESOLUTION OF THE CHOLANGITIS. REPORTEDLY, THE PATIENT HAS BEEN ADMITTED TO A DIFFERENT HOSPITAL IN A DIFFERENT STATE AND THE PHYSICIAN WAS UNABLE TO PROVIDE ADDITIONAL DETAILS, DESPITE EFFORTS.

  Patient problems: Inflammation

  MAUDE report 8529114 ↗
• InjuryOct 18, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT (10X60) WAS IMPLANTED IN A PATIENT WITH A MALIGNANT BILIARY TUMOR OBSTRUCTION DURING A CHOLANGIO WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT WAS AGAIN ADMITTED TO THE HOSPITAL WITH JAUNDICE AND A FAMILY MEMBER REPORTED CONCERN THAT IT WAS POSSIBLY DUE TO OBSTRUCTION. A CHOLANGIOGRAPHY WAS PERFORMED AND CONFIRMED A STENOSIS IN THE DISTAL PORTION OF THE STENT NEAR THE PAPILLA. THE STENT WAS NOTED TO REMAIN IMPLANTED, ANOTHER WALLSTENT BILIARY (10X80) WAS IMPLANTED AND THERE WAS DRAINAGE NOTED AGAIN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Jaundice

  MAUDE report 7982179 ↗
• MalfunctionJul 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A 3CM MALIGNANT STENOSIS IN THE LOWER PART OF THE BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT FAILED TO DEPLOY. REPORTEDLY, SEVERAL ATTEMPTS WERE MADE TO MOVE THE HANDLE OF THE DELIVERY SYSTEM TO START THE DEPLOYMENT, BUT WAS UNSUCCESSFUL. THE STENT WAS FULLY COVERED WITH THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETE 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED UNCROSSED AND BENT STENT WIRES AT ONE END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7731980 ↗
• InjuryApr 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A STRICTURE IN THE COMMON BILE DUCT DUE TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY INSERTING A GUIDEWIRE THROUGH THE DELIVERY SYSTEM THOUGH A STERILE SALINE SOLUTION WAS USED TO FLUSH THE DELIVERY SYSTEM. THE PAPILLA WAS CUT TO GAIN ACCESS IN THE BILE DUCT (PAPILLOTOMY). THE WALLSTENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET AREA AND THE STENT WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, THERE WAS DIFFICULTY DEPLOYING THE PROXIMAL END OF THE STENT. REPORTEDLY, THE WIRE ORDER IN THE OPENED LOOP END OF THE STENT FORMED AN IRREGULAR SHAPE. THE STENT WAS REMOVED WITH A SNARE 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 END OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468744 ↗
• MalfunctionApr 11, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE APPROXIMATELY 3CM LONG IN THE LOWER COMMON BILE DUCT DUE TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 6CM WALLSTENT WAS ABLE TO BE DEPLOYED. HOWEVER, DURING THE REMOVAL OF THE ASSEMBLY, THE DELIVERY SYSTEM GOT CAUGHT ON THE STENT. WHEN THE DELIVERY SYSTEM WAS PULLED OUT FROM THE PATIENT, THE STENT CAME ALONG WITH IT INSTEAD OF BEING DEPLOYED IN THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO 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 7423587 ↗
• MalfunctionDec 21, 2016Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT A WALLSTENT BILIARY STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO PLACEMENT. DURING THE PROCEDURE, THE OUTER SHEATH DETACHED FROM THE HANDLE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT WAS DAMAGED WITH THE WIRES AT THE DISTAL END OF THE STENT BENT AND UNCROSSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6195696 ↗