WALLSTENT™ RX BILIARY M00569660Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729296867), received between Aug 6, 2019 and Mar 3, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2022 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 10MM MALIGNANT OBSTRUCTION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE STENOSIS. THE STENOSIS WAS DILATED AND ANOTHER ATTEMPT TO CROSS THE STENOSIS WAS MADE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660182 ↗
• MalfunctionJun 21, 2021Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Advance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 1.5CM MALIGNANT OBSTRUCTION IN THE MIDDLE AND UPPER COMMON 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 DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION. THE STENT WAS FULLY COVERED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PATIENT FELT DISCOMFORT AND THE PROCEDURE WAS CANCELLED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Discomfort

  MAUDE report 12033736 ↗
• MalfunctionMay 28, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 08, 2020 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A TUMOR IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE RELEASED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT OUTSIDE THE PATIENT. REPORTEDLY, THE CLEAR OUTER SHEATH OPENED A LITTLE BIT BUT THE STENT COULD NOT BE RELEASED FURTHER. PER REVIEW OF THE VIDEO AND PHOTO PROVIDED BY THE COMPLAINANT, THE STENT WIRES WERE BENT. 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 STABLE. DESPITE EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098794 ↗
• InjuryAug 26, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT 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 DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT AT FIRST. WHEN THE PHYSICIAN REMOVED THE DEVICE, SUDDENLY THE STENT DEPLOYED ABOVE THE STRICTURE. THE PHYSICIAN WAS NOT ABLE TO REMOVE THE STENT USING FORCEPS, BASKET, OR OTHER GI ACCESSORIES. ON (B)(6) 2019, THE PATIENT UNDERWENT CHOLEDOCHOJEJUNOSTOMY AND THE STENT WAS REMOVED DURING THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE AND WAS HOSPITALIZED DUE TO THE SURGERY. THE STENT EXPIRED ON (B)(6) 2019, HOWEVER THE PHYSICIAN DECIDED TO USE IT AT HIS OWN DISCRETION.

  Patient problems: No Code Available

  MAUDE report 8932782 ↗
• InjuryAug 15, 2019Difficult or Delayed Positioning; Positioning Problem; Activation Failure; Difficult or Delayed Positioning; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 24, 2019 THAT A WALLSTENT RX BILIARY UNCOVERED STENT WAS USED IN THE LEFT HEPATIC DUCT TO TREAT A JAUNDICE DUE TO MALIGNANT BILIARY STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY. HOWEVER, THE STENT WAS ABLE TO BE DEPLOYED BUT FAILED TO COMPLETELY OPEN. REPORTEDLY, A LARGE PORTION OF THE STENT WAS FOUND INSIDE THE DUODENUM WHILE THE REMAINING PART WAS IN THE HEPATIC DUCT DUE TO ITS INCOMPLETE OPENING. THE DEVICE WAS REMOVED AND ANOTHER WALLSTENT RX BILIARY UNCOVERED STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION RECEIVED ON AUGUST 26, 2019*** ACCORDING TO THE COMPLAINANT, THE STENT PLACEMENT PROCEDURE WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THAT MAY HAVE OCCURRED A FEW DAYS BEFORE (B)(6) 2019. THE STENT WAS BEING PLACED IN A STRICTURE IN THE MIDDLE PART OF THE COMMON BILE DUCT. THE PATIENT'S ANATOMY WAS TORTUOUS A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897692 ↗
• InjuryAug 6, 2019Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 14, 2019 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED IN THE BILIARY TO TREAT CHOLANGIOCARCINOMA DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE STENT FAILED TO FULLY EXPAND AFTER TEN MINUTES CAUSING THE 8 CM STENT TO BE ELONGATED TO ALMOST 12 CM. THE STENT WAS REMOVED WITH A SNARE AND ANOTHER WALLSTENT 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 STABLE. ***ADDITIONAL INFORMATION RECEIVED ON AUGUST 22, 2019*** ACCORDING TO THE COMPLAINANT, THE WALLSTENT BILIARY RX UNCOVERED STENT WAS USED TO TREAT A 4-CM BILIARY STRICTURE DUE TO CHOLANGIOCARCINOMA. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS BUT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864319 ↗