WallFlex™ M00547540Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00191506044527), received between May 19, 2025 and Sep 18, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Activation Failure; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831060 ↗
• InjuryJul 15, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO THE BILE DUCT TO TREAT A TIGHT STRICTURE DUE TO PANCREATIC HEAD MASS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS ONLY IN THE PROXIMAL PART AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE CATHETER AND DEPLOYING THE STENT BEFORE THE STENT WAS FULLY DEPLOYED. AFTER THE STENT WAS FULLY DEPLOYED; THE CATHETER BECAME STUCK ON THE STENT AS THE PHYSICIAN BEGAN WITHDRAWING THE DEVICE FROM THE SCOPE. THE TECHNICIAN ATTEMPTED TO RE-SHEATH THE CATHETER; HOWEVER, THIS WAS UNSUCCESSFUL. THE CATHETER ULTIMATELY BROKE AGAINST THE ELEVATOR, AND THE REMAINING PLASTIC COMPONENT WAS RETRIEVED USING BIOPSY FORCEPS, WHICH INADVERTENTLY PULLED OUT THE ENTIRE STENT. THE PROCEDURE WAS COMPLETED USING A PLASTIC STENT. THERE ARE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829229 ↗
• MalfunctionJun 1, 2026Nonstandard Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A BILE DUCT LEAK DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS TOO SHORT. ANOTHER WALLFLEX BILIARY RX FULLY COVERED STENT WAS USED 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 25350651 ↗
• InjuryMay 25, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX FULLY COVERED STENT WAS IMPLANTED TO TREAT A BILE DUCT STRICTURE IN THE DISTAL COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. REPORTEDLY, THE STENT WAS FOUND TO HAVE MIGRATED FURTHER INTO THE COMMON BILE DUCT (CBD) BUT WAS SUCCESSFULLY REMOVED WITH FORCEPS AND NO RE-STENTING WAS REQUIRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273272 ↗
• InjuryApr 23, 2026Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX FULLY COVERED STENT HAD BEEN IMPLANTED IN THE BILE DUCT TO TREAT A BENIGN STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT ANATOMY WAS NOT TORTUOUS AT THE TIME OF STENT PLACEMENT. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ELEVATED BILIRUBIN LEVELS. A SUBSEQUENT ERCP PROCEDURE REVEALED THAT THE PREVIOUSLY IMPLANTED STENT HAD MIGRATED OUT OF THE BILE DUCT. THE MIGRATED STENT WAS REMOVED USING RATTOOTH FORCEPS. A NON-BOSTON SCIENTIFIC STENT WAS THEN PLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION WAS DESCRIBED AS FULLY RECOVERED AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975198 ↗
• MalfunctionMar 2, 2026Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST PROCEDURE, ON (B)(6) 2026, THE PATIENT CAME FOR A SCHEDULED STENT REMOVAL. UPON ERCP IT WAS FOUND THAT THERE WAS TISSUE INGROWTH ON THE DISTAL FLARE OF THE STENT. THE PHYSICIAN HAD TO PULL SCOPE OUT TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490510 ↗
• InjuryJan 21, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED TO TREAT AN DUCT IN THE DILATION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, A CT SCAN PERFORMED SOMETIME AFTER THE IMPLANT PROCEDURE, REVEALED THE STENT WAS NOT FOUND, IT MIGRATED FROM THE IMPLANT ZONE. ANOTHER ERCP PROCEDURE WAS PERFORMED WHICH CONFIRMED THE STENT WAS NOT IN THE PATIENT AND ANOTHER STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24138068 ↗
• InjuryJan 20, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED FOR A BILE DUCT DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. REPORTEDLY, A CT SCAN PERFORMED SOMETIME AFTER THE IMPLANT PROCEDURE, REVEALED THE STENT WAS NOT FOUND, IT MIGRATED FROM THE IMPLANT ZONE. ANOTHER ERCP PROCEDURE WAS PERFORMED WHICH CONFIRMED THE STENT WAS NOT IN THE PATIENT AND ANOTHER STENT WAS IMPLANTED. FURTHER MEDICAL IMAGING WAS ORDERED TO ENSURE THE STENT EXITED THE PATIENT BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122174 ↗
• InjuryDec 9, 2025Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX STENT SYSTEM COVERED STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT LIVER TRANSPLANT STRICTURE DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT, WHO HAD A LIVER TRANSPLANT, PRESENTED FOR FOLLOW-UP DUE TO DISTAL MIGRATION OF THE STENT OUT OF THE DUCT, WHICH WAS CONFIRMED UNDER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH FLUOROSCOPY. FOLLOW UP PROCEDURE WAS COMPLETED BY IMPLANTING A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE WALLFLEX BILIARY PLUS RX STENT SYSTEM WAS IMPLANTED TO TREAT LIVER TRANSPLANT STRICTURES. HOWEVER, PER THE WALLFLEX BILIARY PLUS RX STENT SYSTEM DIRECTIONS FOR USE (DFU), THE STENT INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS, RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY AND FOR TREATMENT OF BENIGN BILIARY STRICTURES. THE DEVICE IS NOT INTENDED TO TREAT LIVER TRANSPLANT STRICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760647 ↗
• InjuryNov 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX FULLY COVERED STENT WAS IMPLANTED IN THE DUODENUM AND COMMON BILE DUCT TO TREAT A MALIGNANT PANCREATIC HEAD MASS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, DURING AN EMERGENT FOLLOW-UP, THE STENT WAS BELIEVED TO BE OCCLUDED. THE STENT WAS REMOVED USING RAT TOOTH FORCEPS, AND THE PHYSICIAN CONFIRMED THAT DEBRIS WAS PRESENT AROUND THE DISTAL FLANGE. ANOTHER WALLFLEX STENT WAS USED TO REPLACE THE OCCLUDED STENT. THE REINTERVENTION PROCEDURE RESULTED IN ABNORMAL LIVER FUNCTION TESTS (LFTS) AND BLOOD COUNTS. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AS OF (B)(6) 2025, AND REMAINED HOSPITALIZED BEYOND THE STANDARD LEVEL OF CARE.

  Patient problems: Insufficient Information; Liver Damage/Dysfunction

  MAUDE report 23480501 ↗
• InjuryOct 6, 2025Use 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 IMPLANTED IN THE COMMON BILE DUCT (CBD) TO TREAT A POST SPHINCTEROTOMY BLEEDING DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED WITH LOW HEMOGLOBIN LEVELS DUE TO AN INTERNAL BLEEDING. UPON FLUOROSCOPIC INSPECTION, NO EVIDENCE OF STENT MIGRATION INTO THE DUCT WAS OBSERVED. HOWEVER, THE WALLFLEX STENT WAS NOTED TO HAVE MIGRATED OUT OF THE CBD INTO THE SMALL INTESTINE ENDOSCOPICALLY, AND IT WAS THEN REMOVED USING RAT TOOTH FORCEPS AND REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE. ACCORDING TO THE PHYSICIAN'S ASSESSMENT, THE BLEEDING OCCURRED AS THE STENT MIGRATED, AND IT WAS NO LONGER APPLYING PRESSURE ON THE SPHINCTEROTOMY IMPLANT ZONE. THE PATIENT WAS GIVEN BLOOD TRANSFUSION AND WAS EXPECTED TO FULLY RECOVER. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM WAS IMPLANTED TO TREAT A POST SPHINCTEROTOMY BLEEDING. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM DIRECTIONS FOR USE (DFU), THE STENT IS INDICATED FOR USE IN THE PALLIATIVE

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23230036 ↗
• InjuryAug 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX STENT SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL FLANGE WIRES DID NOT LOOK RIGHT, AS THEY APPEARED CLOSED AFTER STENT PLACEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879219 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT A WALLFLEX BILIARY PLUS FULLY COVERED STENT WAS IMPLANTED TO TREAT A STRICTURE DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PERFORMED ON (B)(6) 2025. ON (B)(6) 2025 THE PHYSICIAN EXPLANTED THE STENT BECAUSE IT WAS CAUSING TOO MUCH PRESSURE ON THE BILIARY DUCT RESULTING ON PANCREATITIS IN THE PATIENT. IT IS UNKNOWN IF ANOTHER STENT WAS IMPLANTED AS REPLACEMENT OF THIS DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: Pancreatitis

  MAUDE report 22062867 ↗
• InjuryMay 19, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENTS WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ON (B)(6) 2025 APPROXIMATELY TWO WEEKS, THE STENT MIGRATED DISTALLY INTO DUODENUM. THE PATIENT THEN EXPERIENCED ABNORMAL LFTS AND/OR BLOOD COUNTS. ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT RECEIVED A SURGICAL INTERVENTION TO REMOVE THE MIGRATED STENT.

  Patient problems: Blood Protein Abnormal; Liver Damage/Dysfunction

  MAUDE report 22047311 ↗