WALLSTENT BILIARYRecalls & reported problems across all models

We found 5 models of WALLSTENT BILIARY by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Apr 17, 2026 — classified as 19 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WALLSTENT BILIARY problems

WALLSTENT BILIARY models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WALLSTENT™ BILIARY H965430600

  CATHETER, BILIARY, DIAGNOSTIC
  30 reports
• WALLSTENT™ BILIARY H965430500

  Prosthesis, tracheal, expandable
  13 reports
• WALLSTENT™ BILIARY H965431100

  CATHETER, BILIARY, DIAGNOSTIC
  12 reports
• WALLSTENT™ BILIARY H965431200

  CATHETER, BILIARY, DIAGNOSTIC
  10 reports
• WALLSTENT™ BILIARY H965431000

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports

Recent WALLSTENT BILIARY adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Nonstandard Device; Material Puncture/Hole; Detachment of Device or Device Component; 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 COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE SECONDARY TO CHOLANGITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STAINLESS-STEEL TUBE DETACHED WHILE THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR-REPORTABLE BASED ON INVESTIGATION FINDINGS INDICATING THAT THE INNER SHEATH WAS DETACHED AND THE STENT WIRE PUNCTURED THE CLEAR OUTER SHEATH. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907115 ↗
• InjuryDec 30, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO THE COMMON BILE DUCT TO TREAT AN OBSTRUCTIVE JAUNDICE CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE OPERATOR MONITORED THE ALIGNMENT OF THE PROXIMAL AND DISTAL RADIOPAQUE MARKERS UNDER FLUOROSCOPIC GUIDANCE. MILD RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT, PROMPTING REPOSITIONING AND WIRE MANIPULATION TO ENSURE PROPER ALIGNMENT OF THE MARKERS. DEPLOYMENT WAS INITIATED UNDER COMBINED FLUOROSCOPIC AND ENDOSCOPIC VISUALIZATION. UNEXPECTEDLY, AN EARLY RELEASE OF TENSION DESPITE MAINTAINING CORRECT MARKER POSITIONING AND CONTINUOUS FLUOROSCOPIC OBSERVATION. UPON ASSESSMENT, THE STENT WAS FOUND TO BE FULLY DEPLOYED WITHIN THE COMMON BILE DUCT (CBD), APPEARING SHORT AND PROXIMALLY MIGRATED, RESULTING IN FAILURE TO ACHIEVE ADEQUATE BILIARY DRAINAGE. THE LIKELY CONTRIBUTING FACTORS INCLUDE EXCESSIVE STENT RADIAL FORCE, POSSIBLE PRE-LOADING UNDER TENSION, OR A DEFECT IN THE DELIVERY SYSTEM. THE STENT WAS THEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924845 ↗
• MalfunctionSep 2, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSCOPIC COVERED BILIARY STENT WAS USED TO TREAT A MALIGNANT BILIARY STRICTURE IN THE BILE DUCT DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. CONSEQUENTLY, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935815 ↗
• 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 ↗
• MalfunctionDec 12, 2024Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WIRE WAS POPPING OUT OF THE SHEATH AND SEEMED TO BE BROKEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT, AND IT WAS NOTED THAT THE STENT WIRE PUNCTURED THE OUTER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920570 ↗
• InjuryMay 6, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE AMPULLA OF THE COMMON BILE DUCT (CBD) TO TREAT A MALIGNANT 3 CM MID-CBD STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NARROW AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PROXIMAL FLANGE OF THE STENT DID NOT COMPLETELY EXPAND AFTER SUCCESSFULLY DEPLOYING THE ENTIRE STENT INTO THE TARGET ANATOMY. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250257 ↗
• 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 ↗
• InjuryNov 29, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STENOSIS SECONDARY TO PANCREATIC NEOPLASM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AN ATTEMPT TO PLACE THE STENT IN THE COMMON BILE DUCT WAS PERFORMED; HOWEVER, WHEN THE DEVICE WAS MANEUVERED, THE STENT WAS RELEASED BEFORE REACHING THE TARGET LOCATION. THE STENT WAS REMOVED USING SNARE AND ANOTHER WALLSTENT BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233638 ↗
• InjuryNov 6, 2023Positioning Failure; Defective Device; Positioning Failure; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, STENT DEPLOYMENT COULD NOT BE CONTROLLED IN THE GRADUAL FASHION, BUT THE STENT WAS EVENTUALLY SUCCESSFULLY DEPLOYED INSIDE THE BILE DUCT. HOWEVER, IT WAS NOTED DURING FLUOROSCOPY THAT THE STENT LENGTH WAS SHORTER THAN 6 CM. IT WAS NOTED TO BE "AROUND 3-4." ANOTHER 6 CM STENT WAS IMPLANTED TO BRIDGE THE STRICTURE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079905 ↗
• 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 ↗
• MalfunctionSep 20, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS USED TO TREAT A CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY AND WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT A LATER TIME WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785504 ↗
• MalfunctionJul 17, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 27, 2023, THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT BILIARY TRACT OBSTRUCTION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING UNPACKING, A LITTLE PIECE OF THE TIP WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. 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 17336915 ↗
• 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 ↗
• MalfunctionApr 12, 2022Material Puncture/Hole; Failure to Advance; Material Integrity Problem; Material Puncture/Hole; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE OUTER SHEATH WAS DAMAGED AND THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE STRICTURE. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY. 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 MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRE PUNCTURED THE CLEAR OUTER SHEATH OF THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088631 ↗
• MalfunctionFeb 8, 2022Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BLIARY UNCOVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT JAUNDICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BLIARY 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 RESULT WHICH REVEALED THE TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483458 ↗

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