WALLSTENT Enteral EndoprosthesisRecalls & reported problems across all models

We found 4 models of WALLSTENT Enteral Endoprosthesis by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2017 and Jun 25, 2025 — classified as 18 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 WALLSTENT Enteral Endoprosthesis problems

WALLSTENT Enteral Endoprosthesis models

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

• WALLSTENT™ Enteral Endoprosthesis M00565590

  STENT, COLONIC, METALIC, EXPANDABLE
  15 reports
• WALLSTENT™ Enteral Endoprosthesis M00565580

  STENT, COLONIC, METALIC, EXPANDABLE
  8 reports
• WALLSTENT™ Enteral Endoprosthesis M00565570

  STENT,METALLIC,EXPANDABLE,DUODENAL
  1 report
• WALLSTENT™ Enteral Endoprosthesis M00565650

  STENT, COLONIC, METALIC, EXPANDABLE
  1 report

Recent WALLSTENT Enteral Endoprosthesis adverse event reports

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

• InjuryJun 25, 2025Difficult to Remove; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED ENDOPROSTHESIS WAS IMPLANTED IN THE INTESTINAL TRACT TO TREAT A NON-MALIGNANT INTESTINAL STENOSIS DURING AN INTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE WALLSTENT ENTERAL STENT HAD BURRS AND PRICKED THE MUCOSA, WHICH CAUSED MASSIVE BLEEDING. THE STENT WAS ATTEMPTED TO BE REMOVED USING SNARES AND FORCEPS, BUT THE STENT COULD NOT BE REMOVED TO STOP THE BLEEDING. THE STENT REMAINS IMPLANTED. CONSEQUENTLY, ANOTHER OF THE SAME DEVICE WAS USED, AND THE PHYSICIAN PERFORMED A STENT-IN-STENT TECHNIQUE TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED TO TREAT A NON-MALIGNANT INTESTINAL STENOSIS. THE IFU STATES, "THE WALLSTENT ENTERAL ENDOPROSTHESIS COLONIC/DUODENAL STENT WITH UNISTEP PLUS DELIVERY SYSTEM IS INDICATED FOR PALLIATIVE TREATMENT OF COLONIC, DUODENAL OR GASTRIC OUTLET OBSTRUCTION OR STRICTURES CAUSED BY MALIGNANT NEOPLASMS, AND TO RELIEVE LARGE BOWEL OBSTRUCTION PRIOR TO COLECTOMY IN PATIENTS WITH MALIGNANT STRICTURES." THE WALLS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22330788 ↗
• InjuryDec 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS USED IN THE INTESTINAL TRACT TO TREAT A 2.8 CM LESION SECONDARY TO COLON CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, THE BELL MOUTH AT THE END OF THE STENT SCRATCHED THE PATIENT'S MUCOSA, CAUSING BLEEDING. THE STENT WAS SUBSEQUENTLY REMOVED USING FOREIGN BODY FORCEPS. AFTER ACHIEVING HEMOSTASIS, THE PROCEDURE WAS COMPLETED USING ANOTHER STENT OF THE SAME TYPE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 20915176 ↗
• InjurySep 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT NG ENTERAL UNCOVERED STENT WAS USED IN THE INTESTINAL TRACT FOR INTESTINAL STENOSIS DURING AN INTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER DEPLOYING THE STENT, THE "TIP HAD BURRS" WHICH PRICKED THE MUCOSA AND RESULTED IN BLEEDING. THE STENT COULD NOT BE REMOVED FROM THE PATIENT. ANOTHER WALLSTENT ENTERAL WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 17, 2024*** IT WAS REPORTED THAT THE WIRES AT THE TIP OF THE STENT WERE LIFTED AND BENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20257416 ↗
• InjurySep 10, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT NG ENTERAL UNCOVERED STENT WAS USED IN THE INTESTINAL TRACT DURING AN INTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER DEPLOYING THE STENT, THE "TIP HAD BURRS" WHICH PRICKED THE MUCOSA AND RESULTED IN BLEEDING. THE STENT COULD NOT BE REMOVED FROM THE PATIENT. ANOTHER WALLSTENT ENTERAL WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20183498 ↗
• InjurySep 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN WALLSTENT ENTERAL UNCOVERED STENT WAS USED DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, AND IT WAS FOUND THAT THE TAIL END OF THE STENT WAS SCATTERED, AND THE MUCOSA WAS DAMAGED. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20128931 ↗
• InjuryFeb 19, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS IMPLANTED TO TREAT A 4CM MALIGNANT INTESTINAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, AFTER PLACEMENT OF THE STENT, IT WAS NOTED THAT THE TAIL END OF THE STENT WAS BROKEN AND HAD PUNCTURED THE INTESTINAL MUCOSA, CAUSING BLEEDING. CONSEQUENTLY, ANOTHER WALLSTENT ENTERAL STENT WAS PLACED TO COVER AND COMPRESS THE BLEEDING. THE STENT WAS REMOVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18730997 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED IN THE INTESTINAL TRACT TO TREAT A MALIGNANT 4 CM INTESTINAL OBSTRUCTION DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE BURRS AT THE TIP OF THE STENT CAUSED INTESTINAL PERFORATION. THE PATIENT WAS SENT FOR SURGERY TO ADDRESS THE PERFORATION AND REMOVE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT ENTERAL UNCOVERED STENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 18372071 ↗
• MalfunctionDec 7, 2023Positioning Failure; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT STRICTURE SECONDARY TO DUODENAL CANCER DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED INSIDE THE PATIENT BECAUSE THERE WAS RESISTANCE AT THE TIP OF THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS NOTED THAT A STENT WIRE HAD PUNCTURED THE TIP OF THE OUTER SHEATH. ANOTHER WALLSTENT ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288589 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 20, 2023 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS IMPLANTED TO TREAT A 3CM ANASTOMOTIC STENOSIS IN THE INTESTINAL TRACT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, POST STENT DEPLOYMENT, THE "BURR" ON THE TIP OF THE STENT PUNCTURED THE MUCOUS MEMBRANE WHICH RESULTED TO INTESTINAL BLEEDING. ANOTHER WALLSTENT ENTERAL STENT WAS PLACED FOR COMPRESSION TO RESOLVE THE BLEEDING AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE STENT REMAINED IMPLANTED AND IS SCHEDULED TO BE SURGICALLY REMOVED ON A LATER DATE.

  Patient problems: Bowel Perforation

  MAUDE report 16913042 ↗
• InjuryFeb 21, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLSTENT COLONIC UNCOVERED STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A STRICTURE DUE TO COLON CANCER DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED HALFWAY; HOWEVER, A PART OF THE STENT MESH WAS EMBEDDED IN THE INTESTINAL TRACT TISSUE, AND THE STENT COULD NOT BE RE-SHEATHED, CONSEQUENTLY, THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. THE STENT WAS THEN REMOVED FROM THE PATIENT WITH FORCEPS, AND ANOTHER WALLSTENT COLONIC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 16409604 ↗
• MalfunctionSep 26, 2022Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLSTENT COLONIC STENT WAS TO BE IMPLANTED IN THE INTESTINAL TRACT TO TREAT A 5CM MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLSTENT COLONIC STENT COULD NOT BE DEPLOYED. WHEN THE DEVICE WAS REMOVED, THE WALLFLEX COLONIC STENT ACCIDENTALLY DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT COLONIC STENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15488728 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 18, 2022 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED IN THE COLORECTUM TO TREAT A 4.5 CM STRICTURE DURING AN INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2022. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE STRUT ON BOTH ENDS OF THE STENT PUNCTURED THE PATIENT'S INTESTINAL TRACT. ENTEROSCOPE WAS USED AND BLEEDING WAS NOTED. ELECTRIC COAGULATION HEMOSTASIS WAS DONE TO TREAT THE BLEEDING AND THE BLEEDING WAS RESOLVED. THE WALLSTENT ENTERAL STENT WAS REMOVED FROM THE PATIENT USING SNARES AND ANOTHER WALLSTENT DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 15382454 ↗
• InjuryAug 2, 2022Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLSTENT ENTERAL ENDOPROSTHESIS STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT COLONIC OBSTRUCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE WALLSTENT ENTERAL STENT WAS ATTEMPTED TO BE DEPLOYED, IT WAS UNABLE TO DEPLOY. ANOTHER ATTEMPT TO DEPLOY THE WALLSTENT ENTERAL STENT WAS PERFORMED AND FORCE WAS APPLIED; HOWEVER, THE WALLSTENT ENTERAL STENT WAS DEPLOYED IN AN INCORRECT LOCATION AND HAD PUNCTURED THE INTESTINAL WALL WHICH RESULTED IN PERFORATION. CONSEQUENTLY, AN EMERGENCY SURGERY WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT ENTERAL STENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 15145718 ↗
• InjuryMar 30, 2022Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED IN THE INTESTINAL TRACT TO TREAT A 5 CM TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, THE METAL STENT WIRE WAS LOOSE AND SCRATCHED THE INTESTINAL TRACT. UNDER A SCOPE BLEEDING WAS NOTED. A CLIP AND A DRUG WERE USED TO STOP THE BLEEDING. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT ENTERAL STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. IN THE PHYSICIAN'S OPINION THE STENT DESIGN IS NOT GOOD TO ADAPT TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13955504 ↗
• InjuryMar 25, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 03, 2022 THAT A WALLSTENT ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A 4 CM INTESTINAL TUMOR IN THE COLON DURING A COLON STENT IMPLANTATION PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, AFTER DEPLOYMENT, IT WAS OBSERVED ON IMAGING THAT THE STENT MOVED OUT OF ITS POSITION. THE PATIENT WAS SENT FOR A LAPAROTOMY WHERE THE STENT WAS REMOVED. THE PROCEDURE WAS 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904481 ↗

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