WallFlex™ Duodenal M00555880Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729902515), received between Jul 27, 2022 and Jul 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Activation Failure” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2022Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX DUODENAL SOFT UNCOVERED STENT WAS IMPLANTED TO TREAT A 10CM DUODENAL STRICTURE DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS VERY TIGHT IN THE SECOND AND THIRD PORTION OF THE DUODENUM. ON (B)(6) 2022, THE WALLFLEX DUODENAL STENT WAS SUCCESSFULLY IMPLANTED INSIDE THE PATIENT. HOWEVER, POST PROCEDURE, IT WAS OBSERVED THAT THE PATIENT WAS NOT DECOMPRESSED AND DID NOT RESPOND TO STENT PLACEMENT. ON (B)(6) 2022, IMAGING WAS TAKEN AND THE WALLFLEX DUODENAL STENT WAS FOUND TO BE IN GOOD POSITION; HOWEVER, THE MID PORTION OF THE WALLFLEX DUODENAL STENT WAS NOT FULLY EXPANDED. THE PHYSICIAN REASSESSED THE PATIENT STATUS FOR A SECOND STENT PLACEMENT AND A NASAL GASTRIC TUBE WAS PLACED. REPORTEDLY, 4 TO 5 DAYS AFTER THE INITIAL PLACEMENT, A 22 X 12 WALLFLEX DUODENAL STENT WAS IMPLANTED TO HELP EXPAND THE FIRST WALLFLEX DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS SENT TO HOSPICE FOR PALLIATIVE CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116879 ↗