WallFlex™ Duodenal M00555870Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729902508), received between Feb 4, 2019 and Aug 5, 2025 — classified as 1 death, 1 injury.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS IMPLANTED TO TREAT A DUODENAL OBSTRUCTION IN THE DUODENAL THIRD PORTION DURING A DUODENAL STENT PROCEDURE PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT, WHERE A DUODENAL PERFORATION WAS DIAGNOSED. ON (B)(6) 2025, THE PATIENT WAS INFORMED OF THE COMPLICATION. THE EXACT CAUSE AND CLINICAL DETAILS OF THE PERFORATION REMAIN UNDETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22719746 ↗
• DeathFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 10, 2019 THAT A WALLFLEX DUODENAL SOFT UNCOVERED STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A STENOSIS DUE TO PANCREATIC CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE STENT WAS SUCCESSFULLY IMPLANTED; THE PROXIMAL SIDE OF THE STENT WAS IN THE STOMACH AND THE DISTAL END DID NOT REACH THE PAPILLA. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED THE ENTIRE STENOSIS WAS COVERED, AND NO PROBLEM WAS OBSERVED. ACCORDING TO THE COMPLAINANT, THE PATIENT COULD EAT A 5 MINUTE MEAL PORRIDGE SEVERAL DAYS AFTER STENT PLACEMENT. HOWEVER, IT WAS REPORTED THAT ASCITES PUNCTURE WAS NECESSARY TO PERFORM EVERY DAY. ON (B)(6) 2018, ANEMIA DEVELOPED AND THE PATIENT RECEIVED BLOOD TRANSFUSION. ON (B)(6) 2018, PATIENT'S HEMOGLOBIN COUNT IMPROVED AND THE ANEMIA STOPPED. ON (B)(6) 2018, PATIENT'S HEMOGLOBIN COUNT DECREASED AND THE ANEMIA REDEVELOPED. SYMPTOMS OF ABDOMINAL PAIN WERE ALSO NOTICED BUT OBSERVATION USING AN ENDOSCOPE COULD NOT BE PERFORMED DUE TO THE PATIENT CONDITION. ON (B)(6) 2018, THE PATIENT PASSED AWAY. ON JANUARY 10, 2019 , AN AUTOPSY REPORT WAS RE

  Patient problems: Abdominal Pain; Anemia; Death; Perforation; Peritonitis

  MAUDE report 8300809 ↗