WallFlex™ M00547550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506044497), received between Dec 9, 2025 and Dec 9, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 23760503 ↗