WallFlexRecalls & reported problems across all models

We found 4 models of WallFlex by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between May 19, 2025 and Sep 18, 2026 — classified as 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WallFlex problems

WallFlex models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WallFlex™ M00547540

  Stents, drains and dilators for the biliary ducts
  14 reports
• WallFlex™ M00547530

  Stents, drains and dilators for the biliary ducts
  3 reports
• WallFlex™ M00547550

  Stents, drains and dilators for the biliary ducts
  3 reports
• WallFlex™ M00547520

  Stents, drains and dilators for the biliary ducts
  1 report

Recent WallFlex adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 3, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599389 ↗
• InjuryAug 19, 2026Migration

  It was reported to Boston Scientific Corporation that a Wall flex Biliary Plus RX Fully Covered Stent was implanted in the stomach to treat a malignancy during an EUS-guided Hepatic gastrostomy (EUS-HGS) procedure performed on (b)(6) 2026. The patient's anatomy was not dilated prior to stent placement. During the procedure, the stent was successfully implanted. However, during a follow-up evaluation on (b)(6) 2026, a computed tomography (CT) scan revealed that the Wall Flex biliary stent had migrated into the stomach. A laparoscopic procedure was subsequently performed, and the stent was successfully explanted.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334646 ↗
• 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 ↗
• MalfunctionMay 22, 2026Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY PLUS RX FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026. DURING PREPARATION, PRIOR TO THE PROCEDURE, THE STENT WAS FOUND ALREADY DEPLOYED UPON OPENING THE PACKAGE. ANOTHER WALLFLEX BILIARY PLUS 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 25263129 ↗
• MalfunctionMay 19, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAN AN WALLFLEX BILIARY PLUS RX STENT SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT AREA TO PERFORM AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, PRIOR TO PLACING THE DEVICE OVER THE WIRE, THE PLASTIC PIECE WAS PULLED OUT OF THE CATHETER AND THE STENT PREMATURELY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX PLUS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225522 ↗
• 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 ↗
• 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 23760636 ↗
• 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 23760504 ↗

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