WALLSTENT™ RX BILIARY M00569650Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729296850), received between Jan 8, 2019 and Sep 21, 2021 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT OBSTRUCTIVE JAUNDICE, SECONDARY MALIGNANT TUMORS OF THE PANCREAS AND LIVER AND POSTOPERATIVE COLON CANCER IN THE BILIARY TRACT DURING A TRANSDUODENAL ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS 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 A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRES PROTRUDED FROM THE OUTER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505878 ↗
• InjuryJun 18, 2020Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT OBSTRUCTION IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY DUCT METAL IMPLANTATION 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 WAS DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM, THE CATHETER GOT STUCK AND COULD NOT BE RETRIEVED. THE PHYSICIAN SHOOK THE DELIVERY SYSTEM AND WAS ABLE TO REMOVE THE CATHETER FROM THE PATIENT. HOWEVER, IT WAS NOTICED THATHE STENT WAS DISPLACED OUTWARD. THE STENT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY. 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 10171195 ↗
• InjuryApr 9, 2020Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A 1.5 CM MALIGNANT STRICTURE IN THE LOWER 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, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, DURING CATHETER REMOVAL, THE DELIVERY SYSTEM GOT STUCKED ON THE STENT. THE PHYSICIAN EXERTED FORCE TO REMOVE THE DELIVERY SYSTEM AND THE STENT WAS DISPLACED. THE STENT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 9945818 ↗
• MalfunctionJan 8, 2019Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS DEPLOYED, IT WAS NOTICED THAT THE STENT WAS SHORTER THAN THE LABELED LENGTH. REPORTEDLY, THE STENT APPEARED TO BE 2 CM IN LENGTH WHEN IT SHOULD HAVE BEEN 6 CM. A SECOND WALLSTENT BILIARY WAS IMPLANTED TO PIGGY BACK THE FIRST STENT AND THE PROCEDURE WAS COMPLETE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8229042 ↗