WallFlex™ Colonic M00565120Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729456599), received between Jan 31, 2020 and Mar 19, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS ATTEMPTED TO BE IMPLANTED DURING A COLONIC STENT INSERTION PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE STENT CATHETER BROKE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641362 ↗
• MalfunctionDec 16, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEPLOYMENT CONTROL MECHANISM REPEATEDLY RETRACTED SPONTANEOUSLY. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED. THE PATIENT'S CONDITION WAS UNKNOWN. NOTE: THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817912 ↗
• MalfunctionDec 8, 2025Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO THE INTESTINAL TRACT TO TREAT AN INTESTINAL OBSTRUCTION DURING A PLACEMENT OF INTESTINAL METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2025. PRIOR TO PROCEDURE, IT WAS FOUND THAT THE SEAL PACKAGE WAS DAMAGED DURING CLINICAL INSPECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751767 ↗
• MalfunctionNov 5, 2025Positioning Failure; Difficult to Remove; Material Integrity Problem; Positioning Failure; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A COLONIC STRICTURE DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO DEPLOY THE WALLFLEX COLONIC STENT. THE TECH APPLIED ADDITIONAL PRESSURE TO DEPLOY THE STENT, WHICH RESULTED IN THE TIP OF THE STENT BECOMING BENT. THIS CAUSED DIFFICULTY IN REMOVING THE DEVICE FROM THE SCOPE AND PROLONGED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480296 ↗
• MalfunctionJul 22, 2024Positioning Failure; Difficult to Advance; Positioning Failure; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED IN THE SIGMOID COLON TO TREAT A MALIGNANT BOWEL OBSTRUCTION DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS VERY HARD TO ADVANCE AND RETRACT THE DEVICE THROUGH THE SCOPE. WHEN THE STENT WAS POSITIONED FOR DEPLOYMENT, IT WAS UNABLE TO DEPLOY. THEY REMOVED THE WHOLE SCOPE, AND THE DELIVERY SYSTEM WAS REMOVED THROUGH THE SCOPE. THE PROCEDURE WAS CANCELLED AS THE PHYSICIAN COULD NOT GET ANOTHER DEVICE THROUGH THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795367 ↗
• MalfunctionDec 5, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A 9CM LESION DUE TO A TUMOR DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, A PORTION OF THE STENT GOT STUCK IN THE DELIVERY SYSTEM DESPITE NUMEROUS ATTEMPT TO RELEASE IT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916603 ↗
• InjuryMay 13, 2022Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 21, 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A COLON CANCER DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE RECONSTRAINED BEFORE REACHING THE RECONSTRAINMENT LIMIT MARK. THE STENT WAS DEPLOYED PROXIMAL TO THE STRICTURE. THE STENT WAS REMOVED WITH DIFFICULTY USING RAT-TOOTH FORCEPS AND BLEEDING WAS NOTED. THE BLEEDING HAS RESOLVED ON ITS OWN WITHOUT ANY TREATMENT AND ANOTHER WALLFLEX ENTERAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14402796 ↗
• MalfunctionMar 28, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-01697 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 03, 2022 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE TRANSVERSE COLON AT THE HEPATIC FLEXURE AS A BRIDGE TO SURGERY DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND THE PATIENT WAS SUSPECTED WITH COLON CANCER. DURING THE PROCEDURE, RESISTANCE WAS FELT ON THE STAINLESS STEEL HANDLE OF THE DEVICE AND THE STENT WAS UNABLE TO DEPLOY (THE SUBJECT OF THIS REPORT). WHILE CONTINUING TO ATTEMPT TO DEPLOY THE STENT, THE STAINLESS STEEL HANDLE BENT. THE STENT WAS PARTIALLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. A 90MM WALLFLEX COLONIC STENT (THE SUBJECT MFR. # 3005099803-2022-01697) WAS ATTEMPTED TO BE IMPLANTED; HOWEVER, THE STENT FULLY DEPLOYED BUT REMAINED PARTIALLY INSIDE THE SCOPE. CONSEQUENTLY, THE STENT WAS REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER STENT OF THE SAME SIZE WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934292 ↗
• MalfunctionFeb 28, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 07, 2022 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE INTESTINE TO TREAT OCCLUSION DUE TO COLON CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH ORIGINAL STENT. HOWEVER, THE OCCLUSION PERSISTED AFTER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13620218 ↗
• MalfunctionJul 9, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 18, 2020 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO TREAT A 6-8 CM MALIGNANT TUMOR IN THE SIGMOID COLON DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, PART OF THE STENT GOT STUCK IN THE SCOPE OR THE DELIVERY CATHETER. REPORTEDLY, THE STENT WAS REMOVED ALONG WITH THE SCOPE AND DELIVERY CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO AVAILABILITY OF ANOTHER STENT. THE PROCEDURE WAS RESCHEDULED AND COMPLETED THE NEXT DAY WITH ANOTHER WALLFLEX COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254931 ↗
• InjuryJan 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 10, 2020 THAT A WALLFLEX COLONIC STENT HAS BEEN IMPLANTED IN THE COLON TO TREAT AN EXTRINSIC SEVERE STENOSIS MEASURING 1 CM IN LENGTH X 7 MM IN DIAMETER LOCATED AT 30 CM PROXIMAL TO THE ANUS DURING A GASTROINTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, THE PHYSICIAN NOTICED THAT A PART OF THE DELIVERY CATHETER WAS SHEARED OFF AND WAS LEFT INSIDE THE STENT LUMEN. THE FRAGMENT WAS SUCCESSFULLY REMOVED WITH BIOPSY FORCEPS AND THE STENT REMAINS IMPLANTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656112 ↗