WallFlex™ Biliary M00570620Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729759263), received between Jun 7, 2017 and Dec 4, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 18, 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.

• MalfunctionDec 4, 2020Entrapment of Device; Premature Activation; Difficult to Advance; Entrapment of Device; Premature Activation; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE WALLFLEX BILIARY STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 10, 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DELIVERY SYSTEM THROUGH THE SCOPE. THE DEVICE WAS REMOVED FROM THE SCOPE AND ANOTHER WALLFLEX BILIARY UNCOVERED STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. REPORTEDLY, LATER THAT DAY, THE SAME NON BOSTON SCIENTIFIC SCOPE WAS REPROCESSED AND WAS USED IN A DIFFERENT PROCEDURE. DURING THE PROCEDURE, A SNARE WAS ADVANCED THROUGH THE SCOPE BUT RESISTANCE WAS ENCOUNTERED AND NOTED A DEPLOYED WALLFLEX BILIARY STENT FROM THE PREVIOUS PROCEDURE WAS COMING OUT FROM THE DISTAL END OF THE SCOPE. THE PHYSICIAN THEN REMOVED THE SCOPE AND PULLED THE STENT OUT OF THE SCOPE. REPORTEDLY, THE PREVIOUSLY ADVANCED WALLFLEX BILIARY RX UNCOVERED STENT WAS PREMATURELY DEPLOYED FROM THE CATHETER INSIDE THE SCOPE DURING REMOVAL AND REMAINED IN TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10943382 ↗
• MalfunctionDec 4, 2020Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE WALLFLEX BILIARY STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 10, 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DELIVERY SYSTEM THROUGH THE SCOPE. THE DEVICE WAS REMOVED FROM THE SCOPE AND ANOTHER WALLFLEX BILIARY UNCOVERED STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. REPORTEDLY, LATER THAT DAY, THE SAME NON BOSTON SCIENTIFIC SCOPE WAS REPROCESSED AND WAS USED IN A DIFFERENT PROCEDURE. DURING THE PROCEDURE, A SNARE WAS ADVANCED THROUGH THE SCOPE BUT RESISTANCE WAS ENCOUNTERED AND NOTED A DEPLOYED WALLFLEX BILIARY STENT FROM THE PREVIOUS PROCEDURE WAS COMING OUT FROM THE DISTAL END OF THE SCOPE. THE PHYSICIAN THEN REMOVED THE SCOPE AND PULLED THE STENT OUT OF THE SCOPE. REPORTEDLY, THE PREVIOUSLY ADVANCED WALLFLEX BILIARY RX UNCOVERED STENT WAS PREMATURELY DEPLOYED FROM THE CATHETER INSIDE THE SCOPE DURING REMOVAL AND REMAINED IN TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10943302 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A BILIARY TRACT TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AFTER THE STENT WAS UNPACKAGED, THE STENT WAS PURPOSEFULLY PREDEPLOYED OUTSIDE THE PATIENT AND IT WAS NOTICED THAT THE DISTAL END OF THE STENT WAS BENT AND DEFORMED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10303100 ↗
• InjuryFeb 14, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 21, 2019 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. 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 PREMATURELY DEPLOYED INSIDE THE PATIENT. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339239 ↗
• MalfunctionJun 7, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE PROXIMAL COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. 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 FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX 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 FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE PROXIMAL END OF THE GUIDEWIRE ACCESS SLEEVE WAS DETACHED FROM THE OUTER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6618784 ↗