WALLSTENT™ Enteral Endoprosthesis M00565590Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729285083), received between Sep 19, 2018 and Jun 25, 2025 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 4, 2021Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT AN 8-10CM MALIGNANT INTESTINAL STENOSIS DURING AN ENTEROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT WAS DISLODGED OUT ITS CORRECT LOCATION. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND ANOTHER WALLSTENT ENTERAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. 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 12572747 ↗
• InjuryDec 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 6-7CM COLORECTAL MALIGNANT TUMOR IN THE RECTUM DURING AN INTESTINAL STENT IMPLANTATION PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS FULLY DEPLOYED IN THE RECTUM, IT WAS NOTED THAT THE STENT WIRE AT THE TIP BECAME SPLIT AND PIERCED THE PATIENT'S MUCOSA CAUSING SEVERE BLEEDING. REPORTEDLY, THE PHYSICIAN WAS ABLE TO REMOVE THE STENT OUT OF THE RECTUM MANUALLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT ENTERAL STENT. THE PATIENT RECEIVED DRUG THERAPY TREATMENT TO ADDRESS THE BLEEDING. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 11069062 ↗
• InjuryOct 29, 2020Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS IMPLANTED TO TREAT GASTRIC OUTLET OBSTRUCTION DUE TO PANCREATIC MASS IN THE PYLORUS DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS COMPLETELY DEPLOYED; HOWEVER, THE STENT WAS SLOW TO FULLY EXPAND. A DIFFERENT STENT WAS IMPLANTED INSIDE THE WALLSTENT TO FACILITATE THE EXPANSION OF THE STENT AND TO PROMOTE LUMINAL PATENCY. THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE AS THE SECOND STENT CREATED THE DESIRED PATENCY. 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 AND GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757674 ↗
• MalfunctionSep 15, 2020Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A STENOSIS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT ENTERAL 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE WIRES OF THE STENT PUNCTURED THE CLEAR OUTER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535295 ↗
• MalfunctionSep 19, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE USED TO TREAT AN INTESTINAL OBSTRUCTION DUE TO MALIGNANT STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT FAILED TO DEPLOY WHEN IT REACHED THE STENOSIS ALONG THE GUIDEWIRE IN THE INTESTINAL TRACT. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED UNCROSSED AND KINKED STENT WIRES AT THE DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890809 ↗