WALLSTENT™ RX BILIARY M00569720Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729296928), received between Jun 28, 2018 and Aug 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY RX PARTIALLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A BILIARY STRICTURE DUE TO CHOLANGIOCARCINOMA DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED WITH 1.5 CENTIMETERS OF THE STENT WAS LEFT OUTSIDE THE PAPILLA. HOWEVER, WITHIN 5 SECONDS AFTER COMPLETE DEPLOYMENT, THE WHOLE STENT WAS VACUUMED/ SUCKED INSIDE THE BILE DUCT DUE TO NORMAL PERISTALSIS, LEAVING NO PART OF THE STENT IN THE DUODENUM. REPORTEDLY, THE STENT REMAINS IMPLANTED AND ANOTHER WALLSTENT BILIARY RX PARTIALLY COVERED STENT WAS PLACED INSIDE THE FIRST STENT 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866750 ↗
• MalfunctionJun 28, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT BILIARY RX PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 6 CM MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENTS ANATOMY WAS VERY TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, WHEN THE STENT WAS VIEWED BY THE PHYSICIAN FOLLOWING DEPLOYMENT IT WAS NOTED THAT THE END OF THE STENT WAS NOT 0.5 TO 1 CM OUTSIDE THE COMMON BILE DUCT AS INTENDED. THE STENT POSITIONING MARKER HAD BEEN NOTED TO BE CORRECT PRIOR TO FULL DEPLOYMENT. THE STENT REMAINED IMPLANTED 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648696 ↗