WALLSTENT™ BILIARY H965431100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729317937), received between Nov 8, 2017 and Dec 30, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 4, 2021Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN WALLSTENT BILIARY PARTIALLY COVERED STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STENOSIS DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS OCCLUDED AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE RADIOPAQUE MARKS WERE NOT CORRECTLY SEEN AND THE STENT WAS DEPLOYED DISTALLY TO THE LESION. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED AND ANOTHER WALLSTENT BILIARY STENT 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 STABLE AND OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411015 ↗
• MalfunctionJun 12, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT HAD BEEN IMPLANTED TO TREAT AN APPROXIMATELY 2CM PERIAMPULLARY CARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. 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 DEPLOYED; HOWEVER, THE STENT MIGRATED DISTALLY AFTER DEPLOYMENT. THE STENT REMAINS IMPLANTED AND 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 Consequences Or Impact To Patient

  MAUDE report 10148221 ↗
• InjuryMay 14, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 23, 2020 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 3CM LONG PERIAMPULLARY CARCINOMA IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTOUS AND WAS DILATED ENOUGH PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT MIGRATED DISTALLY AFTER DEPLOYMENT. THE STENT WAS REMOVED WITH RAT TOOTH FORCEPS AND ANOTHER 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059013 ↗
• InjuryDec 12, 2019Difficult or Delayed Positioning; Premature Activation; Difficult or Delayed Positioning; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 19, 2019 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A 3CM PERIAMPULLARY CARCINOMA IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METALIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT BUT NOT TORTUOUS AND WAS NOT DILATED PRIO TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT BECAME STUCK AFTER CROSSING THE POINT OF NO RETURN. THE PHYSICIAN TRIED SEVERAL TIMES TO DEPLOY THE STENT AND SUDDENLY THE STENT DEPLOYED IN A WRONG POSITION. THE STENT WAS REMOVED WITH A DORMIA BASKET AND ANOTHER WALLSTENT BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE THERE WERE NO PATIENT COMPLICATION 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 9460924 ↗
• MalfunctionMay 14, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A 12MM PERIAMPULLARY MALIGNANT STRICTURE IN THE DISTAL COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS FELT WHILE TRYING TO DEPLOY THE STENT. THE PHYSICIAN EXERTED MORE PRESSURE TO THE DELIVERY SYSTEM AND IMMEDIATELY THE STENT CROSSED THE STRICTURE AND WAS DEPLOYED PROXIMAL TO THE STRICTURE. REPORTEDLY, THE STENT REMAINS IMPLANTED AND A 4CM WALLSTENT BILIARY PARTIALLY COVERED STENT WAS PLACED TO COMPLETE THE PROCEDURE. 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 8609132 ↗
• InjuryApr 25, 2019Mechanical Problem; Material Deformation; Positioning Problem; Mechanical Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A 3CM PERIAMPULLARY CARCINOMA IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S AMPULLA WAS TIGHT AND THE REST OF THE CBD WAS DILATED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE STENT HAD BEEN PARTIALLY DEPLOYED THE PHYSICIAN WANTED TO REPOSITION THE STENT BUT IT COULD NOT BE RE-CONSTRAINED. THE STENT WS DEPLOYED INSIDE THE CBD BUT NOT ON THE TARGET SITE. A DORMIA BASKET WAS USED TO TRY TO REPOSITION THE STENT BUT THE ENTIRE STENT CAME OUT FROM THE CBD. THE DORMIA BASKET WAS USED TO REMOVE THE STENT FROM THE PATIENT AND ANOTHER WALLSTENT BILIARY WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PROXIMAL PART OF THE STENT WAS DEFORMED BY BEING GRASPED BY THE DORMIA BASKET DURING REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550940 ↗
• MalfunctionMar 28, 2019Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY PARTIALLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461592 ↗
• InjuryDec 7, 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 BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT. HOWEVER, WHEN THE STENT WAS MORE THAN HALFWAY RELEASED, THE PHYSICIAN EXPERIENCED DIFFICULTY IN DEPLOYING THE PROXIMAL PART OF THE STENT. THE PHYSICIAN ALSO NOTED THAT THE ORDER OF THE STENT WIRES WERE IRREGULAR. A PART AT ONE END OF THE STENT WAS FOUND ¿NOT PROPERLY WEAVED¿ AND A WIRE WAS STICKING OUT. THE STENT WAS REMOVED FROM THE PATIENT 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 7096381 ↗
• MalfunctionNov 8, 2017Break; Break

  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 LESION DUE TO CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DELIVERY SYSTEM BROKE. THE PROCEDURE WAS COMPLETED USING 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. 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 7010405 ↗