WallFlex™ Biliary M00570720Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729759317), received between Dec 20, 2018 and Jul 3, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS IMPLANTED IN THE DISTAL COMMON BILE DUCT TO TREAT A 4-5 CM MALIGNANT BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS INTENTIONALLY DEPLOYED BUT IN THE INCORRECT LOCATION. THE STENT REMAINS IMPLANTED, AND A SECOND WALLFLEX BILIARY STENT WAS PLACED INSIDE THE FIRST WALLFLEX STENT TO REACH THE DUODENUM AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249383 ↗
• InjuryMar 24, 2021Difficult to Remove; Material Deformation; Positioning Problem; Difficult to Remove; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 01, 2021 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT 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. IT WAS REPORTED THAT THE STENT WAS FULLY DEPLOYED IN THE CORRECT POSITION INSIDE THE PATIENT. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. THE PHYSICIAN FORCIBLY PULLED THE DELIVERY SYSTEM TO REMOVE IT; HOWEVER, THE STENT WAS THEN PULLED OUT OF ITS CORRECT POSITION AND WAS RETRIEVED WITH FOCEPS. REPORTEDLY, THE OUTER SHEATH BENT. THE PROCEDURE WAS COMPLETED WITH A WALLFLEX BILIARY FULLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565862 ↗
• MalfunctionDec 2, 2020Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 4CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT 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 SUCCESSFULLY; HOWEVER, UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AND THE SHEATH BUCKLED. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE AFTER THE PROCEDURE WAS PROVIDED BY THE COMPLAINANT AND SHOWS THE SHEATH WAS BUCKLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936246 ↗
• MalfunctionAug 27, 2020Positioning Failure; Material Deformation; Material Integrity Problem; Positioning Failure; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. REPORTEDLY, AFTER REMOVAL OF THE DEVICE FROM THE DUODENOSCOPE, THE INNER SHEATH WAS OBSERVED TO BE KINKED OUT OF THE GUIDEWIRE EXIT PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. 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 STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT COVER WAS DAMAGED (HOLES).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460777 ↗
• MalfunctionDec 20, 2018Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS STUCK AND IT WAS UNABLE TO BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE OUTER SHEATH AT THE DISTAL END WAS PUNCTURED AND THE STENT WIRE WAS EXPOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185497 ↗