WallFlex Biliary M00570350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729953166), received between Jul 27, 2017 and Oct 21, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryOct 21, 2019Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE USED TO TREAT A 1-2CM 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 ABLE TO BE DEPLOYED. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE TIP OF THE CATHETER GOT HOOK ON THE TOP OF THE STENT, AND THE STENT WAS ACCIDENTALLY PULLED OUT FROM ITS POSITION. REPORTEDLY, THE STENT WAS REMOVED WITH A RAT TOOTH GRASPERS 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215976 ↗
• MalfunctionOct 15, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE USED TO TREAT A 5 CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. 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. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE OUTER SHEATH WAS DETACHED/ BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE- ENDOSCOPE INTERFACE (PROXIMAL END OF GAS SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7967200 ↗
• MalfunctionJul 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A 3CM MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TIGHT BUT WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE STENT. IT WAS NOTED THAT THE STENT APPEARED LONGER THAN THE LENGTH INDICATED ON THE PACKAGE. THE STENT WAS FULLY RECONSTRAINED WHEN IT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747306 ↗