WallFlex™ Colonic M00565110Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729456582), received between Feb 15, 2017 and Jan 27, 2026 — classified as 3 deaths, 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Failure to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERNAL STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A MALIGNANT TUMOR (30MMX20MM MODERATE TO SEVERE STENOSIS) DURING AN ENDOSCOPIC INTESTINAL STENTING PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS MODERATE TO SEVERELY STENOSED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANTER WAS STUCK DURING DEPLOYMENT, AND THE STENT WAS PUSHED TO THE FAR END. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190326 ↗
• InjuryJun 12, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE RECTOSIGMOID JUNCTION TO TREAT A COLORECTAL TUMOR DURING AN INTESTINAL STENT IMPLANTATION UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EVENTS REPORTED. FOLLOWING THE PATIENT'S DISCHARGE ON (B)(6) 2025, SYMPTOMS INDICATING POSSIBLE STENT MIGRATION WERE REPORTED, INCLUDING ABSENCE OF BOWEL MOVEMENT AND SENSATION OF THE STENT AT THE ANUS. IMAGING CONFIRMED THE MIGRATION. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOSCOPIC PROCEDURE TO REMOVE THE MIGRATED STENT AND SUCCESSFULLY IMPLANT A REPLACEMENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fecal Incontinence; Incontinence

  MAUDE report 22197609 ↗
• MalfunctionJun 2, 2025Positioning Failure; Difficult to Advance; Material Deformation; Positioning Failure; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT MALIGNANT INTESTINAL STENOSIS DURING A COLONIC STENT IMPLANTATION UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS KINKED AND COULD NOT MOVE FORWARD UNDER FORCE. THE STENT WAS NOT ABLE TO DEPLOY BECAUSE OF THIS, AND THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128062 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED WITHIN THE DESCENDING COLON TO TREAT COLONIC OBSTRUCTION DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN SLOWLY DEPLOYED THE WALLFLEX COLONIC STENT; HOWEVER, AFTER COMPLETE DEPLOYMENT, A SINGLE WIRE FROM THE PROXIMAL FLANGE OF THE WALLFLEX COLONIC STENT WAS FOUND BROKEN UNDER ENDOSCOPIC VIEW. THE PHYSICIAN WAS COMFORTABLE LEAVING THE WALLFLEX COLONIC STENT IMPLANTED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413938 ↗
• DeathMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 9, 2021 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO MINIMIZE A 5 MM INTESTINAL OCCLUSION DUE TO CANCER DURING A COLON STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. IT WAS REPORTED THAT THE PATIENT'S COLON TISSUE WAS VERY UNSTABLE. THE STENT WAS IMPLANTED SUCCESSFULLY, THE OCCLUSION WAS REPORTED TO BE RESOLVED, AND THERE WERE NO COMPLICATIONS. THE PATIENT REMAINED IN THE HOSPITAL FOR A DAY OR TWO BEFORE BEING DISCHARGED. FOUR DAYS POST STENT PLACEMENT, THE PATIENT PRESENTED WITH A MODERATE FEVER. ANTIPYRETIC MEDICATION WAS GIVEN TO THE PATIENT; HOWEVER, THE PATIENT'S FEVER WORSENED. ON (B)(6) 2021 THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND IMAGING WAS PERFORMED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS SENT TO PALLIATIVE SURGERY URGENTLY TO ADDRESS THE PERITONITIS. THE SURGEON SUSPECTS POSSIBLE PERITONITIS CAUSED BY PERFORATION OF THE INTESTINE DUE TO THE STENT. THE PATIENT WAS REPORTED TO BE IN SERIOUS CONDITION IN THE INTENSIVE CARE UNIT. REPORTEDLY, ON (B)(6) 2021, THE PATIENT PASSED AWAY. IT IS UNKNOWN IF THERE WAS A RE

  Patient problems: Bowel Perforation; Fever; Peritonitis

  MAUDE report 11766400 ↗
• InjuryJul 9, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX COLONIC STENT WAS USED TO BE IMPLANTED TO TREAT AN APPROXIMATELY 6CM MALIGNANT TUMOR IN THE SIGMOID COLON DURING A COLONIC STENTING 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 DIFFICULT TO DEPLOY. WHEN THE HUB HANDLE WAS MOVED, THE STENT DEPLOYED TOO FAST. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER WALLFLEX COLONIC STENT WAS IMPLANTED. THE PHYSICIAN WANTED TO PLACE A SECOND STENT TO TELESCOPE PAST THE TUMOR, BUT BECAUSE OF THE AVAILABILITY OF THE DEVICE, THE PROCEDURE WAS CANCELLED AND WAS RESCHEDULED. REPORTEDLY, ON THE NEXT DAY, STENT PLACEMENT PROCEDURE WAS PERFORMED WITHOUT ANY ISSUES. 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 10254508 ↗
• DeathJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX COLONIC STENT HAS BEEN IMPLANTED IN THE SIGMOID COLON TO TREAT COLON CANCER DURING A GASTROINTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, SEVERAL HOURS AFTER THE STENT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN. IT WAS LATER CONFIRMED THAT A PERFORATION OCCURRED. IT IS UNKNOWN WHETHER THE PERFORATION WAS TREATED. THE PATIENT EVENTUALLY PASSED AWAY. REPORTEDLY, THE PATIENT WAS IN POOR CONDITION SO THE CAUSE OF THE PERFORATION AND THE PATIENT'S DEATH COULD NOT BE DETERMINED.

  Patient problems: Abdominal Pain; Death; Perforation

  MAUDE report 8723695 ↗
• InjuryDec 27, 2018Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-62267 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 07, 2018 THAT TWO WALLFLEX COLONIC STENTS HAVE BEEN IMPLANTED TO TREAT A 4CM MALIGNANT STRICTURE IN THE COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2018-62267) WAS DEPLOYED BUT IN AN INCORRECT LOCATION. A SECOND WALLFLEX COLONIC STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED THROUGH THE SCOPE TO EXTEND THE FIRST STENT ACROSS THE STRICTURE; HOWEVER, THE STENT MIGRATED PROXIMALLY DURING DEPLOYMENT. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENTS IN PLACE. A THIRD WALLFLEX COLONIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200486 ↗
• InjuryDec 27, 2018Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-62267 AND 3005099803-2018-62268 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT TWO WALLFLEX COLONIC STENTS HAVE BEEN IMPLANTED TO TREAT A 4CM MALIGNANT STRICTURE IN THE COLON DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED BUT IN AN INCORRECT LOCATION. A SECOND WALLFLEX COLONIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2018-62268) WAS DEPLOYED THROUGH THE SCOPE TO EXTEND THE FIRST STENT ACROSS THE STRICTURE; HOWEVER, THE STENT MIGRATED PROXIMALLY DURING DEPLOYMENT. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENTS IN PLACE. A THIRD WALLFLEX COLONIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200476 ↗
• MalfunctionDec 11, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT HAS BEEN IMPLANTED TO TREAT AN 8CM MALIGNANT TUMOR IN THE DESCENDING COLON DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE, HOWEVER A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE WAS ABLE TO TRAVERSE THE STRICTURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED "TOO QUICKLY" AND WAS PLACED ABOVE THE MASS. REPORTEDLY, THE STENT WAS NOT RETRIEVED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153206 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED AS A BRIDGE TO SURGERY IN THE SIGMOID COLON DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED IN (B)(6) 2018. REPORTEDLY, MALIGNANCY WAS PRESENT AT THE SITE OF STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, TWO OR THREE DAYS POST STENT PLACEMENT, COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND IT WAS NOTICED THAT THE SIGMOID COLON WAS PERFORATED. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION OCCURRED BECAUSE THE PATIENT'S TISSUE WAS FRIABLE AND THE STENT HAS HIGH AXIAL FORCE. REPORTEDLY, A DAY AFTER PERFORATION WAS NOTED, THE PATIENT UNDERWENT EXCISION OF THE SIGMOID COLON AND THE STENT WAS REMOVED DURING THE PROCEDURE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: Bowel Perforation

  MAUDE report 8056899 ↗
• InjuryJan 3, 2018Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED TO TREAT A RECTO-SIGMOIDAL COLONIC STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO RELEASE THE STENT. HOWEVER, ONLY THE DISTAL PART OF THE STENT WAS NOTED TO HAVE EXPANDED. THE PHYSICIAN DECIDED TO KEEP THE STENT IMPLANTED AND THE PATIENT IS SCHEDULED FOR A COLOSTOMY PROCEDURE. REPORTEDLY, THE PATIENT HAS BEEN HOSPITALIZED.

  Patient problems: No Code Available

  MAUDE report 7160464 ↗
• DeathNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE SIGMOID AND DESCENDING COLON TO TREAT A MALIGNANT (T4/N2) COLONIC OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS SOMEWHAT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY. HOWEVER, ON THE SAME DAY AFTER THE PROCEDURE, THE PATIENT WAS IN PAIN. THE PHYSICIAN PERFORMED AN IMAGING PROCEDURE AND THE PATIENT¿S PROXIMAL ANATOMY WAS NOTED TO BE PERFORATED AND THERE WAS FREE AIR IN THE PATIENT'S PERITONEAL SPACE (PNEUMOPERITONEUM); THE PATIENT ALSO PRESENTED WITH SEPSIS. THE PATIENT HAD TO UNDERGO COLONIC RESECTION SURGERY TO REPAIR THE PERFORATION AND WAS GIVEN ANTIBIOTICS TO TREAT THE SEPSIS. THE STENT WAS EXCISED DURING THE SURGERY AND THE PATIENT¿S ANATOMY WAS NOTED TO BE FRIABLE ON THE PROXIMAL SIDE OF THE STRICTURE. IN THE PHYSICIAN¿S ASSESSMENT, THE STENT WAS RELATED TO THE PERFORATION, WHICH CAUSED THE PATIENT TO DEVELOP SEPSIS. ON (B)(6) 2017, THE PATIENT EXPIRED DUE TO SEPSIS.

  Patient problems: Death; No Code Available; Pain; Perforation; Unspecified Infection

  MAUDE report 7068720 ↗
• MalfunctionFeb 15, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 24, 2017 THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE USED IN A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS STARTED TO DEPLOY THE STENT WHEN THE STENT WAS STUCK COULD NOT BE FULLY DEPLOYED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND ANOTHER WALLFLEX COLONIC STENT WAS USED 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 FINE. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6332987 ↗