WallFlex™ Colonic M00565090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729456568), received between Sep 16, 2019 and Jan 29, 2026 — classified as 2 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO THE COLON TO TREAT A 5CM OBSTRUCTION CAUSED BY CANCER DURING AN INTESTINAL STENTING VIA DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PROCEDURE PERFORMED ON (B)(6) 2025. THE ANATOMY OF THE PATIENT WAS TORTUOUS. DURING PROCEDURE, WHEN THE MARK POINT OF THE STENT WAS DEPLOYED HALFWAY, THE STENT SUDDENLY ADVANCED INTO THE BODY OF THE PATIENT, SPECIFICALLY INTO THE INTESTINAL LUMEN, CROSSING THE STENOTIC LESION. REPORTEDLY, SLIGHT RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT. DUE TO THIS EVENT, THE PROCEDURE WAS NOT COMPLETED. THE STENT WAS THEN REMOVED USING BIOPSY FORCEPS VIA COLONOSCOPY. ON (B)(6) 2026, ANOTHER WALLFLEX STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218363 ↗
• MalfunctionSep 24, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT AN INTESTINAL OBSTRUCTION CAUSED BY COLON TUMOR DURING A COLON STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE POSITION OF THE STENT DEVIATED FROM THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE STENT BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE STENT WAS DAMAGED AND DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526147 ↗
• InjurySep 16, 2019Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 22, 2019 THAT A WALLFLEX COLONIC STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT CATHETER WAS INSERTED INTO THE PATIENT'S COLON VIA INTERVENTIONAL RADIOLOGY. DURING DEPLOYMENT, THE PHYSICIAN FELT SOMETHING AS IF IT WAS STUCK AND HAD MORE DIFFICULTY DEPLOYING THE STENT THAN USUAL BUT THE STENT WAS ABLE TO BE DEPLOYED. AN X-RAY WAS TAKEN AND SHOWED THE STENT DID NOT FULLY EXPAND. THE STENT REMAINS IMPLANTED AND REPORTEDLY, THE PHYSICIAN AIMED TO IMPLANT A SECOND WALLFLEX COLONIC STENT WITHIN 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 9071296 ↗