WallFlex DuodenalRecalls & reported problems across all models

We found 6 models of WallFlex Duodenal by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2017 and Sep 17, 2026 — classified as 4 deaths, 48 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (23 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 Duodenal problems

WallFlex Duodenal models

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

• WallFlex™ Duodenal M00565020

  STENT,METALLIC,EXPANDABLE,DUODENAL
  42 reports
• WallFlex™ Duodenal M00565030

  STENT,METALLIC,EXPANDABLE,DUODENAL
  2 deaths38 reports
• WallFlex™ Duodenal M00565010

  STENT,METALLIC,EXPANDABLE,DUODENAL
  1 death30 reports
• WallFlex™ Duodenal M00555860

  Stent, metallic, expandable, duodenal
  2 reports
• WallFlex™ Duodenal M00555870

  Stent, metallic, expandable, duodenal
  1 death2 reports
• WallFlex™ Duodenal M00555880

  Stent, metallic, expandable, duodenal
  1 report

Recent WallFlex Duodenal adverse event reports

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

• MalfunctionSep 17, 2026Premature Activation; Difficult to Advance

  It was reported to Boston Scientific Corporation that a WallFlex Esophageal Stent was attempted to be implanted in the duodenum to treat a duodenal stricture during a Stent placement for duodenal stricture procedure performed on (b)(6) 2026. It was reported that during procedure, the device would not fit down the pediatric colonoscope channel. Due to the tightness of the channel, the stent was inadvertently deployed in the channel. The stent was removed from the patient, and the procedure was completed using another of the same device.There is no patient complications reported as a result of the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803998 ↗
• MalfunctionAug 14, 2026Deformation Due to Compressive Stress; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261972 ↗
• MalfunctionJul 28, 2026Difficult or Delayed Positioning; Use of Device Problem; Activation, Positioning or Separation Problem; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063589 ↗
• MalfunctionJul 17, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX DUODENAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE INTESTINES DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (b)(6) 2026. DURING THE PROCEDURE WHEN DEPLOYED, THE STENT FELL OFF IN ADVANCE, THE DEPLOYMENT WAS NOT ACCURATE, AND THE THERAPEUTIC EFFECT COULD NOT BE ACHIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860690 ↗
• MalfunctionMay 7, 2026Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A DUODENAL OBSTRUCTION IN THE DUODENUM DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, BURRS WERE IDENTIFIED AT THE DISTAL END OF THE STENT, AND THE SURFACE OF THE STENT WAS NOT SMOOTH. ALSO, ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE STENT WAS REMOVED IN A PARTIALLY DEPLOYED STATE TOGETHER WITH THE DELIVERY SYSTEM. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117983 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS IMPLANTED TO TREAT A DUODENAL OBSTRUCTION IN THE DUODENAL THIRD PORTION DURING A DUODENAL STENT PROCEDURE PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT, WHERE A DUODENAL PERFORATION WAS DIAGNOSED. ON (B)(6) 2025, THE PATIENT WAS INFORMED OF THE COMPLICATION. THE EXACT CAUSE AND CLINICAL DETAILS OF THE PERFORATION REMAIN UNDETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22719746 ↗
• InjuryApr 4, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED TO TREAT A 5CM ANATOMIC STRICTURE IN THE DUODENUM CAUSED BY GASTRIC AND DUODENUM CANCER DURING A GASTROSCOPY WITH INTRODUCTION OF DUODENAL STENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT BROKE INTO TWO PARTS. THE BROKEN STENT REMAINS IMPLANTED, AND ANOTHER STENT WAS PLACED THROUGH IT. REPORTEDLY, THE PHYSICIAN DID NOT REMOVE THE STENT DUE TO BLEEDING AND THE ANATOMIC STRICTURE CAUSED BY THE TUMOR. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21775149 ↗
• MalfunctionFeb 27, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A 3-7 MM MALIGNANT LESION IN THE DUODENUM DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND REPORTEDLY PRESENTED WITH ABDOMINAL PAIN. DURING THE PROCEDURE, THE STENT TIP BECAME DEFORMED (CURVED). THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER WALLFLEX ENTERAL DUODENAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21484644 ↗
• InjuryJan 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A 2 CM MALIGNANT DUODENAL STENOSIS DURING A COLONOSCOPY WITH DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED IN THE CORRECT LOCATION. HOWEVER, IT WAS REPORTED THAT THE STENT WAS REMOVED FROM THE PATIENT USING RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL STENT. DUE TO THE AMBIGUITY OF THE EVENT, BOSTON SCIENTIFIC CONSIDERED THE WORST-CASE SCENARIO: THE STENT WAS UNABLE TO EXPAND DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212235 ↗
• MalfunctionJan 9, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A 5CM MALIGNANT STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE MORE DISTAL PART OF THE STENOSIS INSTEAD OF THE INTENDED LESION SITE. REPORTEDLY, THE STENT WAS SCHEDULED TO BE REMOVED ONE WEEK AFTER THE PROCEDURE. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21119580 ↗
• MalfunctionOct 17, 2024Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT STOMACH CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. DUE TO PHYSICIAN DISCRETION, IT WAS DECIDED TO TERMINATE THE PROCEDURE WITHOUT PLACING ANY IMPLANT OR DEVICE. REPORTEDLY, THE PATIENT WAS UNDER PALLIATIVE MANAGEMENT AND PASSED AWAY LATER ON AN UNKNOWN DATE DUE TO REASONS NOT RELATED TO THE REPORTED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472235 ↗
• InjuryOct 8, 2024Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED IN THE DUODENUM DURING AN IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT IT FULLY DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS THEN ATTEMPTED TO BE REMOVED, BUT DIFFICULTY WAS ALSO ENCOUNTERED WHICH CAUSED OBSTRUCTION OF THE RESPIRATORY TRACT. THE PROCEDURE WAS NOT COMPLETED BECAUSE THE PATIENT EXPERIENCED RESPIRATORY DISTRESS, AND THE PATIENT WAS THEN TREATED WITH ADDITIONAL OXYGEN SUPPLEMENTS. IN THE PHYSICIAN'S ASSESSMENT THE STENT CAUSED THE OBSTRUCTION OF THE AIRWAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE FOR RESPIRATORY TRACT MONITORING AND THE PATIENT IS EXPECTED TO FULLY RECOVER. NOTE: IT WAS REPORTED THAT THE STENT CAUSED OBSTRUCTION OF THE RESPIRATORY TRACT. THE IFU STATES, " THE WALLFLEX DUODENAL STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTIONS PRODUCED BY MALIGNANT NEOPLASMS." THE WALLFLEX DUODENAL STENT IS NOT INDICATED TO BE USED IN THE RESPIRATORY TRACT.

  Patient problems: Airway Obstruction; Respiratory Insufficiency

  MAUDE report 20400620 ↗
• MalfunctionSep 30, 2024Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, WHEN OPENING THE PACKAGE, IT WAS NOTED THAT THE STENT HAD ALREADY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334687 ↗
• DeathJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT GASTRODUODENAL STRICTURE, DURING A PALLIATIVE ENDOSCOPIC STENT TREATMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PATIENT SUFFERED A PERFORATION. WHICH WAS CONFIRMED, UNDER KIDNEY, URETER AND BLADDER X-RAY (KUB). ON (B)(6) 2024, THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF THE PATIENT'S DEATH WAS THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 19652154 ↗
• MalfunctionJun 21, 2024Activation Failure; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02964 AND 3005099803-2024-02965 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS TO BE IMPLANTED IN THE GASTRODUODENAL JUNCTION TO TREAT A MALIGNANT STRICTURE AS A PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO EXPAND AS MUCH AS THE PHYSICIAN DESIRED. ANOTHER WALLFLEX ENTERAL DUODENAL STENT WAS USED BUT THE SAME PROBLEM OCCURRED. 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 19589098 ↗

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