WallFlex™ Biliary M00570660Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729759287), received between Feb 2, 2018 and May 27, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO THE COMMON BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, IN THE ATTEMPT TO DEPLOY THE STENT, THE STENT WAS KINKED AND MALFUNCTIONED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303099 ↗
• MalfunctionAug 14, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DELIVERY HANDLE WOULD NOT MOVE, AS A RESULT, THE STENT WOULD NOT DEPLOY. THE PROCEDURE WAS CANCELLED, AND NO OTHER STENTS WERE IMPLANTED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986546 ↗
• InjuryJun 13, 2024Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY UNCOVERED STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT LONG STRICTURE BETWEEN THE LEFT INTRAHEPATIC DUCT AND THE COMMON HEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE DELIVERY SYSTEM COULD NOT BE REMOVED. THEY ATTEMPTED TO RESHEATH THE STENT BUT WAS UNABLE TO PROCEED PAST HALFWAY UP THE DUCT. SUBSEQUENTLY, THE DELIVERY SYSTEM WAS CUT USING A RAT-TOOTH FORCEPS FROM INSIDE THE PATIENT WHILE A STANDARD SCISSOR WAS USED FROM THE OUTSIDE OF THE BIOPSY CAP. THE STENT REMAINED IMPLANTED ALONG WITH A PORTION OF THE INNER SHEATH. ANOTHER WALLFLEX BILIARY UNCOVERED STENT WAS IMPLANTED STENT-IN-STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19533458 ↗
• MalfunctionNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, PRIOR TO STENT DEPLOYMENT, THE PHYSICIAN FELT THAT THE STENT'S LENGTH WAS NOT THE LABELED LENGTH. THE STENT APPEARED TO BE TOO LONG INSIDE THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828081 ↗
• MalfunctionNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, PRIOR TO STENT DEPLOYMENT, THE PHYSICIAN FELT THAT THE STENT'S LENGTH WAS NOT THE LABELED LENGTH. THE STENT APPEARED TO BE TOO LONG INSIDE THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827899 ↗
• MalfunctionNov 18, 2022Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, PRIOR TO STENT DEPLOYMENT, THE PHYSICIAN FELT THAT THE STENT'S LENGTH WAS NOT THE LABELED LENGTH. THE STENT APPEARED TO BE TOO LONG INSIDE THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. NOTE: THE REPORTED UPN AND LOT NUMBER WAS NOTED TO BE PAST ITS EXPIRY DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827664 ↗
• MalfunctionSep 15, 2022Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX BILIARY UNCOVERED STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT WAS NOTED TO BE DEFECTIVE. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH OF THE WALLFLEX BILIARY STENT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429381 ↗
• InjuryFeb 12, 2020Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A 7CM MALIGNANT STRICTURE FROM THE COMMON BILE DUCT TO INTRAHEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO EXPAND AFTER COMPLETE DEPLOYMENT. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS NOT COMPLETED DUE TO SAME DEVICE WAS UNAVAILABLE. THE PROCEDURE WAS RESCHEDULED TO MID OF FEBRUARY, EXACT DATE IS UNKNOWN. 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 9700319 ↗
• MalfunctionJan 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT HAS BEEN IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE CATHETER BROKE APART FROM THE PUSHING CATHETER. REPORTEDLY, THE STENT WAS WRAPPED AROUND THE SMALLER CATHETER INSIDE OF THE SHEATH. THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED EXCEPT FOR THE INNER CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 FINE. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2020*** ACCORDING TO THE COMPLAINANT, THE INNER SHEATH WAS NOT REMOVED AS THE PATIENT WAS DRAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9624140 ↗
• InjuryApr 8, 2019Difficult or Delayed Positioning; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Difficult or Delayed Positioning; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT HAS BEEN IMPLANTED IN THE HILAR REGION DUE TO CHOLANGIOCARCINOMA DURING A DUODENOSCOPY WITH BILATERAL BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, A NON-BSC STENT HAD BEEN IMPLANTED IN THE LEFT SIDE AND THE WALLFLEX BILIARY RX UNCOVERED STENT WAS BEING IMPLANTED ON THE RIGHT SIDE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY DEPLOYING THE STENT DUE TO THE VERY TIGHT STRICTURE. EVENTUALLY, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE DELIVERY SYSTEM COULD NOT BE REMOVED THROUGH THE STENT AND FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN SHOOK AND STRETCHED THE DELIVERY SYSTEM IN THE ATTEMPT TO RELEASE THE DELIVERY SYSTEM FROM THE STENT, BUT, IT WAS UNSUCCESSFUL. THE PHYSICIAN CUT THE HANDLE PART OF THE DELIVERY SYSTEM, THE REST OF THE DELIVERY SYSTEM WAS BROUGHT THROUGH THE PATIENT'S NOSE AND LEFT WITHIN THE PATIENT, AND THE PROCEDURE WAS ENDED. REPORTEDLY, THE PHYSICIAN PLANNED TO REMOVE THE DELIVERY SYSTEM IN ANOTHER PROCEDURE. THE PATIENT WAS THEN SENT TO INTENSIVE CARE UNIT FOR OBSERVATION DUE TO CHRONIC PANCREATITIS. REPORTE

  Patient problems: Inflammation

  MAUDE report 8491199 ↗
• MalfunctionDec 13, 2018Use of Device Problem; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Use of Device Problem; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT HILAR BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHIPPING MANDREL WAS MANUALLY REMOVED PRIOR TO LOADING THE GUIDEWIRE. DURING THE PROCEDURE, THE GUIDEWIRE FAILED TO EXIT AT THE GUIDEWIRE RX PORT, AND THE OUTER SHEATH OF THE DELIVERY SYSTEM WAS BENT. THE STENT AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS FOUND BROKEN/DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160335 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WOULD NOT DEPLOY IN THE COMMON BILE DUCT. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS DETACHED/BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE ¿ ENDOSCOPE INTERFACE (PROXIMAL END OF THE GAS SECTION).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726443 ↗
• InjuryJun 28, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE INITIAL STENT PLACEMENT, THE STENT WAS DISLODGED AND FELL INTO THE INTESTINAL TRACT. THE STENT WAS REMOVED WITH FORCEPS, AND ANOTHER WALLFLEX 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648561 ↗
• InjuryFeb 2, 2018Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-00144 AND THIS REPORT FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO WALLFLEX BILIARY RX UNCOVERED STENTS WERE TO BE USED TO TREAT AN APPROXIMATELY 6-7 CM MALIGNANT LESION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS VERY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE FIRST STENT (THE SUBJECT OF THIS REPORT) AND THE SECOND WALLFLEX BILIARY RX STENT (SUBJECT OF THIS REPORT). HOWEVER, A COUPLE OF THE LOOPS ON THE END OF THE TWO STENTS WERE BROKEN INTO PIECES. THE PHYSICIAN REMOVED BOTH STENTS USING FORCEPS AND 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238014 ↗
• InjuryFeb 2, 2018Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-00144 AND 3005099803-2018-00145 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 11, 2018 THAT TWO WALLFLEX BILIARY RX UNCOVERED STENTS WERE TO BE USED TO TREAT AN APPROXIMATELY 6-7 CM MALIGNANT LESION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS VERY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE FIRST WALLFLEX BILIARY RX STENT (SUBJECT OF MFR REPORT # 3005099803-2018-00144) AND THE SECOND STENT (THE SUBJECT OF THIS REPORT). HOWEVER, A COUPLE OF THE LOOPS ON THE END OF THE TWO STENTS WERE BROKEN INTO PIECES. THE PHYSICIAN REMOVED BOTH STENTS USING FORCEPS AND 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237997 ↗