WallFlex™ Biliary M00570500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729764885), received between Aug 14, 2018 and Oct 2, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Positioning Problem” (2 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.

• InjuryOct 2, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT BILIARY STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WOULD NOT FULLY EXPAND. THE STENT WAS REMOVED FROM THE PATIENT WITH A FOREIGN BODY DEVICE, AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353678 ↗
• InjuryJan 11, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A BENIGN STENOSIS IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT WAS NOTED THAT THE STENT WAS INCORRECTLY PLACED NEAR THE HEPATIC DUCTS. THE STENT WAS REMOVED WITH BIOPSY FORCEPS AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13224789 ↗
• InjuryAug 14, 2018Difficult to Remove; Use of Device Problem; Positioning Problem; Difficult to Remove; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED TO TREAT A STENOSIS IN THE MIDDLE AND DISTAL THIRD PART OF COMMON BILE DUCT WHICH WAS CAUSED BY INFILTRATION SECONDARY TO GASTRIC CANCER DURING A PERCUTANEOUS BILIARY STENT PLACEMENT UNDER FLUOROSCOPIC GUIDANCE PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT HAD GASTRECTOMY FOR GASTRIC CANCER. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO DE DEPLOYED, HOWEVER, ONE OF THE STENT WIRE EDGES GOT STUCK IN THE CATHETER WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED. SUBSEQUENT TO REMOVAL OF THE DELIVERY SYSTEM, A CEPHALIC MIGRATION OF THE STENT OCCURRED. THE STENT WAS LEFT IMPLANTED INSIDE THE PATIENT AND A PERCUTANEOUS BILIARY DRAINAGE CATHETER WAS PLACED FOR BILIARY DRAINAGE. REPORTEDLY, THE PROCEDURE WILL BE CONTINUED ON AN UNKNOWN DATE TO IMPLANT A SECOND BSC STENT. THERE WERE NO SERIOUS INJURIES AND NO ADVERSE EFFECTS FOR THE PATIENT. NOTE: ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A HISTORY OF GASTRECTOMY FOR GASTRIC CANCER WHICH PREVEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780892 ↗