WallFlex™ Biliary M00570520Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729764908), received between Dec 8, 2016 and Mar 4, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryMar 4, 2026Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED INTO THE BILE DUCT TO TREAT A BENIGN BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUOUS AND WAS DILATED PRIOR TO THE PLACEMENT OF THE STENT. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT. AFTER THE STENT WAS FULLY DEPLOYED, IT WAS FOUND TO BE POSITIONED IN AN UNDESIRED LOCATION. DUE TO THIS, THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY STENT WAS USED TO TREAT A BENIGN STRICTURE. HOWEVER, PER THE WALLFLEX BILIARY RX COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS AND RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY. THE DEVICE IS NOT INDICATED TO BE USED FOR THE TREATMENT OF BENIGN STRICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514519 ↗
• MalfunctionNov 12, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT WALLFLEX STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANCY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, THE PATIENT HAS A TORTUROUS ANATOMY. DURING PROCEDURE, IT WAS REPORTED THAT THE STENT IS NOT FULLY DEPLOYED. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535974 ↗
• InjuryDec 19, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT POST PAPILLECTOMY DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(3) 2023, THE PATIENT RETURNED TO THE HOSPITAL AFTER EXPERIENCING SEVERE ABDOMINAL PAIN. IT WAS LATER NOTED DURING A COMPUTED TOMOGRAPHY (CT) SCAN THAT THE STENT MIGRATED INTO THE DUODENUM, WHICH RESULTED IN PERFORATION. SURGERY WAS PERFORMED TO REMOVE THE STENT AND TO ADDRESS THE PERFORATION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE POOR.

  Patient problems: Abdominal Pain; Perforation; Sepsis

  MAUDE report 18355324 ↗
• MalfunctionAug 9, 2021Break; Activation, Positioning or Separation Problem; Material Deformation; Material Integrity Problem; Break; Activation, Positioning or Separation Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A BILIARY TRACT TUMOR IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT COVER AND STENT RETRIEVAL LOOP WERE DAMAGED AND THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293723 ↗
• MalfunctionDec 4, 2020Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A STENOSIS IN THE COMMON BILE DUCT DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT COVER WAS DAMAGED (HOLES).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10943441 ↗
• MalfunctionDec 4, 2020Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A STENOSIS IN THE BILE DUCT DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY INSIDE 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 STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT COVER WAS DAMAGED WITH HOLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10943403 ↗
• InjuryOct 11, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 18, 2019 THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE USED TO TREAT A 2-3 CM STRICTURE CAUSED BY CHOLEDOCHAL TUMOR IN THE COMMON BILE DUCT DURING A BILIAY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. 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 MOVED OUT OF ITS POSITION AFTER DEPLOYMENT. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX 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 Consequences Or Impact To Patient

  MAUDE report 9180045 ↗
• InjuryOct 3, 2018Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A 2CM 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 NOT TIGHT AND WAS NOT DILATED PRIOR TO THE STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED BUT IN AN INCORRECT LOCATION. THE STENT WAS REPOSITIONED BY PULLING THE RETRIEVAL LOOP WITH A RAT TOOTH GRASPING FORCEPS. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN MIGHT HAVE PULLED ONLY ONE RETRIEVAL LOOP WHICH RESULTED TO MALFORMATION/ UNRAVELING OF THE STENT RETRIEVAL LOOP. THE STENT WAS REMOVED AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7932144 ↗
• InjuryMar 19, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A 2 CM 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 NOT TORTUOUS AND WAS NOT DILATED PRIOR TO THE STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT STENT RETRIEVAL LOOP WAS FOUND FOLDED POST DEPLOYMENT. THE STENT WAS REMOVED WITH A RAT TOOTH FORCEPS AND ANOTHER WALLFLEX BILIARY RX STENT WAS USED 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 7350910 ↗
• MalfunctionDec 27, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS NOTED AND THE STENT WOULD NOT OPEN. REPORTEDLY, THE PHYSICIAN AND THE NURSE HEARD A SNAP. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE ¿ ENDOSCOPE INTERFACE (AT THE PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148933 ↗
• MalfunctionNov 7, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE USED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS BROKEN AT THE PROXIMAL END OF THE GUIDEWIRE ACCESS SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7007878 ↗
• MalfunctionAug 10, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT IT WAS ¿MORE DIFFICULT THAN USUAL¿ TO PASS THE GUIDEWIRE THROUGH THE CATHETER, BUT EVENTUALLY THEY WERE ABLE TO SUCCESSFULLY PASS IT THROUGH. DURING DEPLOYMENT, THE SHEATH WAS NOTED TO HAVE BEEN STRETCHED AND BROKE AT THE GUIDEWIRE ACCESS PORT. THE STENT FAILED TO DEPLOY INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX COVERED 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 6786423 ↗
• InjuryApr 5, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2017-00957 AND 3005099803-2017-00958 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT TWO WALLFLEX BILIARY RX COVERED STENTS WERE USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DUE TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TIGHT BUT 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 MFR. REPORT #3005099803-2017-00957). DURING REMOVAL OF THE DELIVERY SYSTEM THE TIP OF THE DELIVERY SYSTEM GOT STUCK IN THE MIDDLE PORTION OF THE STENT, WHERE THE STRICTURE WAS LOCATED, AND THE TIP DETACHED INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE STENT AND THE DETACHED TIP WITH A SNARE. THE SECOND STENT ( THE SUBJECT OF MFR. REPORT #3005099803-2017-00958) WAS USED BUT THE SAME THING OCCURRED. THE SECOND STENT AND DETACHED TIP WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6461474 ↗
• MalfunctionFeb 22, 2017Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX¿ BILIARY RX STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN DEPLOYING THE STENT. THE STENT WAS FULLY DEPLOY; HOWEVER BASED ON THE PHOTOS PROVIDED, THE STENT WAS NOTED TO BE DAMAGED. THE STENT REMAINS IMPLANTED 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 6350639 ↗
• MalfunctionDec 8, 2016Difficult to Remove; Difficult to Remove

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2016-03753 AND 3005099803-2016-03752 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 14, 2016 THAT TWO WALLFLEX BILIARY RX COVERED STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST STENT ¿POPPED¿ DURING DEPLOYMENT (THE SUBJECT OF MFR REPORT # 3005099803-2016-03753). THE PHYSICIAN REMOVED THE FIRST STENT AND SUCCESSFULLY DEPLOYED A SECOND WALLFLEX BILIARY STENT (THE SUBJECT OF MFR REPORT # 3005099803-2016-03752); HOWEVER, WHEN THE PHYSICIAN REMOVED THE DELIVERY SYSTEM, IT ALSO PULLED THE STENT OUT OF THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING PATIENT¿S CONDITION HAS BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6156121 ↗