WALLSTENT™ BILIARY H965431200Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729229902), received between Aug 14, 2017 and Sep 2, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 8, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A 4 CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WIRE PUNCTURED THE OUTER SHEATH. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11958198 ↗
• MalfunctionMar 24, 2020Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METAL STENTING PROCEDURE PERFORMED ON (B)(6), 2019. REPORTEDLY, PATIENT'S ANATOMY WAS NOT TORTUOUS BUT THE STRICTURE WAS TIGHT CAUSING OBSTRUCTION. THE STRICTURE WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FORCE WAS APPLIED TO DEPLOY THE STENT, BUT THE STENT FAILED TO DEPLOY. 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRES PUNCTURED THE CLEAR OUTER SHEATH OF THE DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9875368 ↗
• MalfunctionJul 1, 2019Difficult or Delayed Positioning; Premature Activation; Material Deformation; Difficult or Delayed Positioning; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 11, 2019 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A 4 CM MALIGNANT STENOSIS IN THE COMMON BILE DUCT (CHOLEDOCH) DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NORMAL AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH WAS RETRACTED TO DEPLOY THE STENT BUT BECAME KINKED. REPORTEDLY, THE STENT WAS RELEASED 50% INSIDE THE ENDOSCOPE. THE DEVICE WAS ATTEMPTED TO BE REMOVED AND SUDDENLY, THE STENT DEPLOYED IN THE DIGESTIVE TRACT. REPORTEDLY, THE STENT REMAINS IMPLANTED AND ANOTHER WALLSTENT BILIARY WAS PLACED 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 OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748656 ↗
• MalfunctionJul 1, 2019Break; Difficult or Delayed Positioning; Positioning Problem; Break; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A 25MM PANCREATIC TUMOR IN THE MID COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. REPORTEDLY, THE PATIENT'S PROGNOSIS WAS BAD AND THE PATIENT CANNOT TOLERATE ANY INTERVENTION OTHER THAN STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE GUIDEWIRE WAS IN PLACED AND THE STENT WAS POSITIONED AT THE MIDDLE OF THE STENOSIS. DURING THE PROCEDURE, PRESSURE WAS FELT AND THE STENT WAS UNABLE TO BE DEPLOYED. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT SEVERAL TIMES TO CHECK ITS FUNCTIONALITY. THE PHYSICIAN THEN REINSERTED THE DEVICE TO THE PATIENT AND ATTEMPTED TO DEPLOY THE STENT. REPORTEDLY, THE BLUE MARKER WAS POSITIONED AT THE PAPILLA AND DURING STENT DEPLOYMENT, RESISTANCE WAS FELT WHILE PULLING THE OUTER SHEATH AROUND THE STENT. THE PLASTIC HANDLE WAS DETACHED FROM THE BLUE OUTER SHEATH AND THE STENT WAS DEPLOYED. HOWEVER, IT WAS NOTICED THAT 1CM OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748625 ↗
• MalfunctionDec 27, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENTING PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO CROSS THE LESION BUT, THE STENT FAILED TO DEPLOY AFTER SEVERAL ATTEMPTS. THE DEVICE WAS REMOVED AND NOTICED THAT IT WAS BROKEN. IT WAS NOT REPORTED AT WHAT LOCATION THE DEVICE BROKE. REPORTEDLY, 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 FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200059 ↗
• MalfunctionMar 7, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS STUCK IN THE DELIVERY SYSTEM AND COULD NOT BE DEPLOYED. THE STENT WAS REMOVED 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321341 ↗
• MalfunctionAug 14, 2017Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TIGHT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT WHEN IT WAS TESTED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE WALLSTENT BILIARY STENT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6791686 ↗