WallFlex ColonicRecalls & reported problems across all models

We found 13 models of WallFlex Colonic by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 168 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2017 and Sep 24, 2026 — classified as 8 deaths, 76 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WallFlex Colonic problems

WallFlex Colonic models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WallFlex™ Colonic M00565050

  STENT, COLONIC, METALIC, EXPANDABLE
  2 deaths63 reports
• WallFlex™ Colonic M00565060

  STENT, COLONIC, METALIC, EXPANDABLE
  2 deaths33 reports
• WallFlex™ Colonic M00565040

  STENT, COLONIC, METALIC, EXPANDABLE
  1 death23 reports
• WallFlex™ Colonic M00565110

  STENT, COLONIC, METALIC, EXPANDABLE
  3 deaths14 reports
• WallFlex™ Colonic M00565120

  STENT, COLONIC, METALIC, EXPANDABLE
  11 reports
• WallFlex™ Colonic M00565100

  STENT, COLONIC, METALIC, EXPANDABLE
  8 reports
• WallFlex™ Colonic M00555770

  Stent, colonic, metallic, expandable
  4 reports
• WallFlex™ Colonic M00565080

  STENT, COLONIC, METALIC, EXPANDABLE
  3 reports
• WallFlex™ Colonic M00565090

  STENT, COLONIC, METALIC, EXPANDABLE
  3 reports
• WallFlex™ Colonic M00555780

  Stent, colonic, metallic, expandable
  3 reports
• WallFlex™ Colonic M00565130

  STENT, COLONIC, METALIC, EXPANDABLE
  1 report
• WallFlex™ Colonic M00565140

  STENT, COLONIC, METALIC, EXPANDABLE
  1 report
• WallFlex™ Colonic M00565150

  STENT, COLONIC, METALIC, EXPANDABLE
  1 report

Recent WallFlex Colonic adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Premature Activation; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884367 ↗
• 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 ↗
• MalfunctionJul 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876856 ↗
• 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 ↗
• InjuryMar 10, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS IMPLANTED INTO THE COLON TO TREAT A STRICTURE CAUSED BY CANCER DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, A ZEBRA GUIDEWIRE WAS INSERTED INTO THE NARROWED CAVITY AND PASSED TO THE DISTAL END ON THE SIDE OF THE LESION. THEN, A STENT PUSHER WAS INTRODUCED ALONG THE GUIDEWIRE. UNDER THE DIRECT VISION OF THE ENDOSCOPE, IT WAS CONFIRMED AND THEN SLOWLY RELEASED. THE BOTTOM YELLOW MARK OF STENT WAS NOT CLEARLY MARKED. IT WAS OBSERVED THAT THE STENT WAS NOT POSITIONED PROPERLY, WHICH CAUSED SOME OF THE LESIONS TO BE NOT FULLY COVERED. TO RESOLVE THE ISSUE, A NON-BOSTON SCIENTIFIC STENT WAS ADDED ON THE ANAL SIDE OF THE LESION. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559708 ↗
• MalfunctionFeb 11, 2026Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED TO TREAT AN APPROXIMATELY 2CM MALIGNANT COLONIC STRICTURE DURING A COLONOSCOPY PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS REPORTED TO BE TIGHT DUE TO THE STRICTURE BUT WAS NOT CONSIDERED TORTUOUS. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DEPLOY THE STENT. DEPLOYMENT HAD ONLY REACHED APPROXIMATELY THE MID-POINT, AND THE RADIOPAQUE (RO) MARKER HAD NOT YET REACHED THE POINT OF NO RETURN WHEN THE PHYSICIAN OBSERVED THAT THE STENT HAD ALREADY BEEN FULLY DEPLOYED TOWARD THE SPLENIC FLEXURE. THE STENT REMAINS IMPLANTED AND ANOTHER WALLFLEX ENTERAL COLONIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS NOTED TO HAVE FULLY RECOVERED FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317099 ↗
• InjuryJan 29, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED TO THE COLON TO TREAT A 5CM OBSTRUCTION CAUSED BY CANCER DURING AN INTESTINAL STENTING VIA DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PROCEDURE PERFORMED ON (B)(6) 2025. THE ANATOMY OF THE PATIENT WAS TORTUOUS. DURING PROCEDURE, WHEN THE MARK POINT OF THE STENT WAS DEPLOYED HALFWAY, THE STENT SUDDENLY ADVANCED INTO THE BODY OF THE PATIENT, SPECIFICALLY INTO THE INTESTINAL LUMEN, CROSSING THE STENOTIC LESION. REPORTEDLY, SLIGHT RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT. DUE TO THIS EVENT, THE PROCEDURE WAS NOT COMPLETED. THE STENT WAS THEN REMOVED USING BIOPSY FORCEPS VIA COLONOSCOPY. ON (B)(6) 2026, ANOTHER WALLFLEX STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218363 ↗
• 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 ↗
• InjuryJan 20, 2026Difficult or Delayed Positioning; Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC ENTERAL STENT WAS TO BE IMPLANTED IN THE INTESTINES TO TREAT INTESTINAL OBSTRUCTION DUE TO MALIGNANT TUMORS DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS (TIGHT) PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, IT FELL OFF PREMATURELY, THE DEPLOYMENT WAS NOT ACCURATE, AND THE THERAPEUTIC EFFECT COULD NOT BE ACHIEVED. IT WAS FURTHER REPORTED THAT THE ADVANCER WAS STUCK AND THE RELEASE WAS INACCURATE. THE STENT WAS THEN REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117334 ↗
• MalfunctionJan 19, 2026Activation, Positioning or Separation Problem; 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 IN THE SIGMOID COLON TO TREAT AN INTESTINAL OBSTRUCTION DUE TO SIGMOID COLON CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CONNECTION AT THE FRONT SECTION OF THE WALLFLEX STENT HAD BECOME MISALIGNED, AND IT WAS NOTED THAT THE STENT HAD BURRS ON THE SURFACE. THE STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112037 ↗
• InjuryJan 8, 2026Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT SIGMOID STENOSIS DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY AND ADVANCE. IT WAS NOTED THAT THE STENT FAILED TO EXPAND; HENCE, THE STENT WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 21, 2026: IT WAS LATER CONFIRMED THAT A PART OF THE STENT WAS ATTACHED TO THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003826 ↗
• MalfunctionJan 7, 2026Positioning Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT A MALIGNANT STENOSIS DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS SEVERELY TORTUOUS. DURING THE PROCEDURE, THE STENT DID NOT EXPAND PROPERLY AND WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 14, 2026*** IT WAS REPORTED THAT THE STENT DID NOT DEPLOY AND WAS REMOVED WITHOUT USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996636 ↗
• InjuryJan 6, 2026Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS TO BE IMPLANTED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT ANATOMY WAS TORTUOUS (TIGHT) PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT FULLY EXPAND AND SHIFTED FROM THE TARGETED POSITION. THEREFORE, FORCEPS WAS USED TO REMOVED THE UNEXPANDED STENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982123 ↗
• 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 ↗

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