WallFlex™ Biliary M00570890Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729765332), received between Nov 17, 2016 and Jan 7, 2026 — classified as 7 injuries, 5 malfunctions.

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

• MalfunctionJan 7, 2026Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT WHILE PREPARING A 10MM X 40MM WALLFLEX BILIARY UNCOVERED STENT FOR PLACEMENT, THE STENT UNINTENTIONALLY DEPLOYED DURING REMOVAL OF THE INNER SHEATH PRIOR TO BEING HANDED TO THE PHYSICIAN. THE DEVICE WAS RENDERED UNUSABLE AND WAS NOT DEPLOYED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999651 ↗
• MalfunctionNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 28, 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 15828799 ↗
• InjuryJan 6, 2022Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT, EXTRINSIC PANCREATIC MASS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO THE STENT PLACEMENT PROCEDURE. FIVE DAYS POST STENT PLACEMENT, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH CHOLANGITIS. IMAGING WAS PERFORMED, AND IT WAS NOTED THAT THE STENT DID NOT FULLY EXPAND. REINTERVENTION VIA ERCP WAS PERFORMED AND TWO PLASTIC STENTS WERE IMPLANTED WITHIN THE WALLFLEX BILIARY STENT TO ALLOW FOR BILIARY DRAINAGE. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE WALLFLEX BILIARY UNCOVERED STENT IMPLANTED. THE PATIENT WAS REPORTED TO BE FULLY RECOVERED AND THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Inflammation

  MAUDE report 13176714 ↗
• InjuryAug 26, 2021Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY AND WAS UNABLE TO BE REPOSITIONED. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375327 ↗
• InjuryOct 9, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 14, 2020 THAT A WALLFLEX BILIARY UNCOVERED STENT WAS IMPLANTED TO TREAT A BILIARY OBSTRUCTION HILAR MASS IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, DURING REMOVAL OF THE CATHETER, THE INNER CATHETER WAS STUCK IN THE BILE DUCT AND EVENTUALLY BROKE OFF. REPORTEDLY, AFTER 2 HOURS OF SEVERAL ATTEMPTS AND DIFFERENT TECHNIQUES, THE INNER CATHETER WAS REMOVED BY PULLING IT HARD AND THE STENT REMAINS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT WAS SENT HOME AFTER THE PROCEDURE. REPORTEDLY, THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL A DAY OR TWO AFTER THE PROCEDURE DUE TO A BLEED. IT WAS ALSO NOTED THAT THE PATIENT GOT PANCREATITIS. IT IS UNKNOWN IF OR HOW THE BLEEDING AND PANCREATITIS WERE TREATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation

  MAUDE report 10657374 ↗
• MalfunctionNov 8, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. 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 ATTEMPTED TO BE DEPLOYED STENT-IN-STENT WITHIN AND EXTENDING PROXIMAL TO A PREVIOUSLY PLACED STENT. THE TARGET ANATOMY WAS A TIGHT TURN INTO THE COMMON HEPATIC DUCT. HOWEVER, DURING DEPLOYMENT, THE STENT PREMATURELY DEPLOYED ABOVE THE PRIOR STENT, INSTEAD OF WITHIN IT. REPORTEDLY, ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO CONNECT THE TWO STENTS AND THE PROCEDURE WAS COMPLETED. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297710 ↗
• InjuryAug 20, 2018Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT DID NOT OPEN; IT REMAINED CLOSED AND WAS IMPOSSIBLE TO PLACE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION AND/ OR SPECIFIC INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798890 ↗
• MalfunctionAug 22, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017, THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A 2 CM MALIGNANT STRICTURE CAUSED BY PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE STENT BUT THE OUTER SHEATH BROKE CLOSE TO THE GUIDEWIRE ACCESS PORT. THE STENT WAS REMOVED FROM THE PATIENT FULLY CONSTRAINED 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 6810681 ↗
• MalfunctionJul 26, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 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 PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER BROKE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 21, 2017. THE COMPLAINANT REPORTED THAT THEY WERE REFERRING TO THE CLEAR SHEATH WHEN THEY STATED THAT THE CATHETER BROKE. THE BROKEN PIECE REMAINED ATTACHED TO THE DELIVERY SYSTEM AND THE STENT WAS FULLY CONSTRAINED WHEN IT WAS REMOVED FROM THE PATIENT. 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 6744641 ↗
• InjuryFeb 27, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 02, 2017 THAT A WALLFLEX BILIARY UNCOVERED STENT WAS IMPLANTED ON (B)(6) 2016 AS PART OF THE (B)(6) TRIAL. THE PATIENT HAD A HISTORY OF AMPULLARY CANCER AND WAS ENROLLED INTO GROUP B PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS PRIOR TO CURATIVE INTENT SURGERY; WITH OR WITHOUT NEOADJUVANT THERAPY. ON (B)(6) 2016, AN ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS WAS TAKEN AND REPORTED JAUNDICE, ITCHING, DARK URINE, AND PALE STOOLS. LIVER FUNCTION TEST WAS TAKEN ON (B)(6) 2016. IMAGING (ERCP, CT, AND EUS) AND TISSUE DIAGNOSIS USING FINE NEEDLE ASPIRATION (FNA) WAS WITH A RESULT OF MALIGNANT NEOPLASM THAT IS DEEMED RESECTABLE. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2016. DURING THE STENT PLACEMENT PROCEDURE, A PANCREATOGRAM AND BILIARY SPHINCTEROTOMY WERE PERFORMED, AND THE STUDY STENT WAS IMPLANTED IN A SATISFACTORY MANNER. ON (B)(6) 2016, DUE TO DISEASES PROGRESSION, THE PATIENT WAS TRANSITIONED TO PALLIATIVE MANAGEMENT AND WILL NOT UNDERGO CURATIVE INTENT SURGERY. ON (B)(6) 2017, THE STUDY STENT WAS NOTED TO BE OCCLUDED DUE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6361386 ↗
• InjuryDec 28, 2016Partial Blockage; Partial Blockage

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 06, 2016 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(6) CLINICAL TRIAL. THE PATIENT HAD A HISTORY OF PANCREATIC CANCER AND A PRIOR PLASTIC BILIARY STENT. THE PATIENT WAS ENROLLED IN THE STUDY FOR TREATMENT OF MALIGNANT NEOPLASMS WITH NO INTENDED SURGERY. ON (B)(6) 2015, AN ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS (ABOS) WAS TAKEN AND REPORTED RIGHT UPPER QUADRANT PAIN. LIVER FUNCTION TESTS WERE ALSO PERFORMED ON (B)(6) 2015. THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY (MRCP), CT SCAN AND ENDOSCOPIC ULTRASOUND (EUS) WITH FINE NEEDLE ASPIRATION (FNA) FOR IMAGING/TISSUE SAMPLING DURING THE STENT PLACEMENT PROCEDURE ON (B)(6) 2015. THE PROCEDURE WAS DONE IN AN INPATIENT SETTING AND A PANCREATOGRAM WAS PERFORMED DURING THE PROCEDURE. ADDITIONALLY, THE PLASTIC BILIARY STENT WAS REMOVED DURING THE PROCEDURE. THE STUDY STENT WAS IMPLANTED ON (B)(6) 2015 IN A SATISFACTORY MANNER DURING THE ERCP. ON (B

  Patient problems: Jaundice; Nausea; Vomiting

  MAUDE report 6210845 ↗
• InjuryNov 17, 2016Partial Blockage; Partial Blockage

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT A WALLFLEX" BILIARY RX FULLY UNCOVERED STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016 AS PART OF (B)(6). A BASELINE ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS WAS CONDUCTED AND THE FOLLOWING SYMPTOMS WERE REPORTED: DARK URINE, PALE STOOLS, AND JAUNDICE. THE PATIENT'S BASELINE KARNOFSKY SCORE WAS REPORTED AS 90, AND THE PATIENT'S WEIGHT WAS REPORTED TO BE (B)(6). BASELINE LIVER FUNCTION TESTS WERE TAKEN ON (B)(6) 2016. THE PATIENT UNDERWENT PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT), ENDOSCOPIC ULTRASOUND (EUS), CHEST X-RAY, AND EUS FINE NEEDLE ASPIRATION (FNA), AND A STAGE IIA  T3 -N0 M0, A 4.3 CM ADENOCARCINOMA TUMOR WAS IDENTIFIED AT THE HEAD AND BODY OF THE PANCREAS. ON (B)(6) 2016, THE PATIENT UNDERWENT STUDY STENT PLACEMENT AS AN OUTPATIENT PROCEDURE. A SPHINCTEROTOMY WAS PERFORMED DURING THIS PROCEDURE, AND THE 10MM X 40MM WALLFLEX BILIARY UNCOVERED STENT WAS PLACED IN A SATISFACTORY MANNER. ON (B)(6) 2016, THE PATIENT EXPERIENCED A SERIOUS ADVERSE EVENT OF CHOLANGITIS. ACCORDING TO THE COMPLAINANT, THE EVENT IS RELATED TO THE STUDY STENT AND WAS NOTED TO BE SEVERE. ON (B)

  Patient problems: Unspecified Infection

  MAUDE report 6110595 ↗