WallFlex Biliary M00570340Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729953159), received between Apr 20, 2020 and Jul 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT RMV WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS AND FOR PROPHYLAXIS BLEEDING TREATMENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, POST STENT PLACEMENT, THE PATIENT STARTED BLEEDING. ON (B)(6) 2025, THE PATIENT UNDERWENT A REPEAT ERCP, AND THE PHYSICIAN FOUND THE BLEEDING ULCER INSIDE THE DISTAL DUCT WALL. BIPOLAR CAUTERY WAS APPLIED, FOLLOWED BY THE PLACEMENT OF A RESOLUTION CLIP AND THE ADMINISTRATION OF HEMOSPRAY. IN THE PHYSICIAN'S ASSESSMENT, THE PRESSURE ULCER CONTRIBUTED TO THE BLEEDING, WHICH WAS CAUSED BY THE WALLFLEX STENT. THE STENT REMAINS IMPLANTED, AND THE PATIENT IS CURRENTLY ADMITTED AND UNDER OBSERVATION SINCE THE HEMOGLOBIN STARTED TO DROP. IN THE PHYSICIAN'S ASSESSMENT, THE HEMOGLOBIN LEVEL OF THE PATIENT STABILIZED AFTER THE PRESSURE ULCER WAS TREATED. ON ON (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANT

  Patient problems: Anemia; Erosion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer

  MAUDE report 22613829 ↗
• InjuryApr 23, 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 APRIL 03, 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE TIP OF THE DEPLOYMENT CATHETER GOT CAUGHT ON THE STENT AND BROKE OFF. THE BROKEN PARTS OF THE DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT USING SNARE. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH THIS 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992862 ↗
• InjuryApr 20, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2020, THE PATIENT RETURNED TO THE HOSPITAL AND THE STENT WAS NOTED TO HAVE MIGRATED OUT. A PLASTIC STENT WAS IMPLANTED TO ENSURE DRAINAGE. ON (B)(6), 2020, ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED. 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. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2020*** IT WAS REPORTED THAT THE WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS INDICATED TO TREAT A MALIGNANT STRICTURE IN THE DISTAL BILE DUCT. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH DEHYDRATION AND JAUNDICE. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND CONFIRMED THAT THE STENT HAD COMPLETELY MIGRATED AND PASSED OUT NATURALLY FROM THE PATIENT. PER THE PHYSICIAN, THE STRICTURE LIKELY SHRANK DUE TO CHEMOTHERAPY.

  Patient problems: Dehydration; Jaundice; No Code Available

  MAUDE report 9977433 ↗