WallFlex™ Colonic M00555770Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729902591), received between Jun 1, 2022 and Sep 21, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; 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 treat stenosis during a colonic stent placement procedure performed on (b)(6) 2026.During a standard colonic stent placement procedure, two stents experienced deployment issues and became stuck on the guidewire. Consequently, both stents, along with their respective delivery systems, were withdrawn and removed from the patient. One of the stents was reported to be partially deployed at the time of removal. The procedure was successfully completed using a different device and model.There were no patient complications as a result of this event and the patient condition following the procedure was stable.Note: This event has been deemed an MDR reportable event based on the investigation results which revealed that the stent was observed in a deformed condition with distortion of the stent structure. Additionally, breaks within the stent wire structure were identified, with multiple wire segments observed separated from the nominal stent configuration. Please see Block H11 for full investigation details.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842567 ↗
• InjuryMay 22, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC SOFT UNCOVERED STENT WAS IMPLANTED IN THE DESCENDING COLON TO TREAT A MALIGNANT TUMOR DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED BEFORE REACHING THE POINT OF NO RETURN MARKER ON THE HANDLE, CONSEQUENTLY, THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. ANOTHER WALLSTENT COLONIC STENT WAS PLACED STENT-IN-STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374669 ↗
• MalfunctionJul 24, 2023Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  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 5 CM MALIGNANT COLONIC STRICTURE DURING A COLONIC SELF-EXPANDABLE METALLIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TIGHT PRIOR TO STENT PLACEMENT. DURING STENT DEPLOYMENT, THE FLARED END OF THE STENT WOULD NOT OPEN. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT BY PUSHING THE OUTER SHEATH BACK TO THE DISTAL TIP OF THE DELIVERY SYSTEM, BUT THE OUTER SHEATH BECAME STUCK, AND THE STENT WIRE BROKE. THE WALLFLEX COLONIC STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS NOT COMPLETED AS THE PATIENT WAS REPORTED TO BE WEAK. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE STENT OUTSIDE OF THE PATIENT PARTIALLY COVERED BY THE OUTER SHEATH. ONE OF THE STENT'S WIRES CAN BE OBSERVED TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378723 ↗
• InjuryJun 1, 2022Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2022-02899 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 10, 2022 THAT TWO WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEMS WERE IMPLANTED TO TREAT A MALIGNANT COLONIC STRICTURE IN THE SIGMOID COLON AND AS A BRIDGE TO SURGERY DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC SOFT STENT (THE SUBJECT OF THIS REPORT) WAS ABLE TO BE DEPLOYED BUT AFTER STENT DEPLOYMENT, THE STENT WAS NOT VISIBLE UNDER ENDOSCOPIC VIEW. THE PHYSICIAN SUSPECTED A STENT MALFUNCTION AND DECIDED TO REMOVE THE DELIVERY SYSTEM. A SECOND WALLFLEX COLONIC SOFT STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2022-02899) WAS DEPLOYED; BUT THE SAME PROBLEM OCCURRED, THE SECOND STENT WAS NOT VISIBLE UNDER ENDOSCOPIC VIEW. HOWEVER, WHEN THE PHYSICIAN CHECKED UNDER FLUOROSCOPY, IT WAS NOTED THAT TWO WALLFLEX COLONIC SOFT STENTS WERE IMPLANTED IN AN INCORRECT POSITION. THE STENTS REMAIN IMPLANTED AND THE PROCEDURE WAS STOPPED AS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568619 ↗