WallFlex™ Colonic M00565080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729456551), received between Jun 14, 2018 and Dec 11, 2024 — classified as 1 injury, 2 malfunctions.

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.

• MalfunctionDec 11, 2024Use of Device Problem; Material Deformation; Material Integrity Problem; Use of Device Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE USED IN THE INTESTINAL TRACT TO TREAT A BENIGN STENOSIS DURING AN ENTERECTOMY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS NOTED THAT THE STENT TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE WALLFLEX ENTERAL STENT WAS USED TO TREAT A BENIGN INTESTINAL STENOSIS. HOWEVER, PER THE WALLFLEX COLONIC STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF COLONIC STRICTURES PRODUCED BY MALIGNANT NEOPLASM AND TO RELIEVE LARGE BOWEL OBSTRUCTION PRIOR TO COLECTOMY IN PATIENTS WITH MALIGNANT STRICTURES. THE DEVICE IS NOT INDICATED FOR THE TREATMENT OF BENIGN STRICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903031 ↗
• MalfunctionJun 22, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2023, THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A STRICTURE DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING STENT DEPLOYMENT, THE STAINLESS-STEEL HANDLE BROKE IN HALF, AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER OF THE SAME DEVICE WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187546 ↗
• InjuryJun 14, 2018Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 23, 2018 THAT A WALLFLEX COLONIC STENT WAS TO BE USED TO TREAT A COLONIC STENOSIS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE STENT FAILED TO FULLY EXPAND ON ONE END. THE STENT WAS REMOVED WITH FORCEPS AND 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. X-RAY IMAGE OF THE WALLFLEX COLONIC DEPLOYED WITHIN THE PATIENT WAS RECEIVED AND SEEMS TO SHOW AN UNEXPANDED PORTION OF THE STENT WITHIN THE ANATOMY. VIDEO OF THE PHYSICIAN MANIPULATING THE STENT AFTER IT WAS REMOVED FROM PATIENT WAS ALSO RECEIVED AND APPEARS TO SHOW THAT THE FLARED END OF THE STENT WAS SLIGHTLY UNEXPANDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601963 ↗