WallFlex™ Colonic M00565100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729456575), received between Feb 2, 2018 and Dec 18, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A STRICTURE DUE TO CANCER DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING DEPLOYMENT, THE WIRES OF THE STENT BROKE, AND THE STENT LOST ITS FORM. THE STENT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND THE STENT WAS NOTED TO BE DEFORMED, AND THE WIRES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20965852 ↗
• MalfunctionDec 23, 2020Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 30, 2020 THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, THE STENT PREMATURELY DEPLOYED INSIDE THE SCOPE WHEN THE DELIVERY SYSTEM WAS INSERTED INTO THE SCOPE. ANOTHER WALLFLEX COLONIC STENT WAS IMPLANTED 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 11070099 ↗
• MalfunctionDec 12, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 22, 2019 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A MALIGNANT OBSTRUCTION IN THE COLON DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED THROUGH THE STENOSIS. THE PHYSICIAN WAS ABOUT TO ADVANCE THE STENT TO CROSS THE STENOSIS WITH THE HELP OF THE GUIDEWIRE; HOWEVER, THE GUIDEWIRE COULD ONLY ADVANCE A SMALL PART OF THE GUIDEWIRE LUMEN IN THE STENT. THE GUIDEWIRE AND THE STENT WAS REMOVED TOGETHER FROM THE PATIENT AND IT WAS NOTED THAT THE METAL STENT WAS VISIBLY KINKED. ANOTHER WALLFLEX COLONIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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 9461500 ↗
• MalfunctionOct 12, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A MALIGNANT STENOSIS IN THE COLON DURING A BOWEL STENTING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE STENT WIRES ON BOTH ENDS WERE NOTED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960419 ↗
• MalfunctionSep 6, 2018Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A MECHANICAL BOWEL OBSTRUCTION IN THE COLON CAUSED BY ILEUS CANCER DURING A 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, AT FIRST THE STENT WAS EASILY DEPLOYED. HOWEVER, WHEN ATTEMPTING TO FULLY DEPLOY THE STENT, IT WAS UNABLE TO COMPLETELY RELEASE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. A PHOTO OF THE STENT WAS RECEIVED AND BASED ON THIS, THE STENT WAS NOTED TO BE DAMAGED AT THE END. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX COLONIC STENT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852788 ↗
• InjuryJul 25, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT AN OMNIPRESENT STENOSIS IN THE COLON DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT HAD A HISTORY OF COLON CANCER. THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, DURING PROCEDURE, RESISTANCE WAS FELT MIDWAY AND THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS PULLED TOGETHER WITH THE ENDOSCOPE, BUT THE STENT PREMATURELY DEPLOYED INSIDE THE PATIENT AND SHIFTED FROM THE TARGET STENOSIS. THE STENT AND DELIVERY SYSTEM WERE REMOVED WITH ENDOSCOPE AND FORCEPS. REPORTEDLY, THE PROCEDURE WAS DISCONTINUED DUE TO UNAVAILABILITY OF ANOTHER WALLFLEX COLONIC STENT. ON (B)(6) 2018, THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720313 ↗
• InjuryMay 3, 2018Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A STRICTURE IN THE COLON CAUSED BY A TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TIGHT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED HOWEVER, IT FAILED TO EXPAND IN THE INTENDED PLACEMENT AREA. THE STENT WAS THEN REMOVED FROM THE PATIENT AND NOTICED THE STENT HAD EXPANDED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A 9CM 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7485524 ↗
• InjuryFeb 2, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED TO TREAT A STRICTURE IN THE LARGE INTESTINE DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PHYSICIAN TRIED TO REMOVE THE DELIVERY SYSTEM AFTER THE STENT WAS IMPLANTED, THE INNER SHEATH WAS DETACHED INSIDE THE PATIENT, SO IT WAS RETRIEVED USING A GRASPING FORCEPS. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237979 ↗