WALLSTENT™ Enteral Endoprosthesis M00565580Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729285076), received between May 21, 2018 and Dec 12, 2024 — classified as 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 30, 2021Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT COLORECTAL TUMOR DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY; THE STENT PENETRATED INTO THE PATIENT'S MUCOSA AND CAUSED BLEEDING. A BALLOON AND PLACEMENT OF ANOTHER STENT WAS USED TO ADDRESS THE BLEEDING AND COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

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

  MAUDE report 12891012 ↗
• InjuryAug 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 14, 2021 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 3- 3.5 CM MALIGNANT COLORECTAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED THAT THE STENT WIRES WERE BENT AND PRODDED THE PATIENT'S INTESTINAL TRACT WHICH CAUSED BLEEDING. CLIP AND HEMOSTATICS WERE USED TO ADDRESS THE BLEEDING AND THE STENT WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12284795 ↗
• MalfunctionFeb 25, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT COLONIC UNCOVERED STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT AN INTESTINAL STENOSIS DURING STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. ANOTHER WALLSTENT COLONIC 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. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT WIRES WERE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377830 ↗
• MalfunctionMay 21, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE DUODENOJEJUNAL FLEXURE DUE TO PANCREATIC ADENOCARCINOMA DURING AN ENDOSCOPIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DUODENAL STENT WAS POSITIONED UNDER RADIOLOGIC AND ENDOSCOPIC VIEW WITH THE OPAQUE MARKERS PLACED AT THE CENTER OF THE DUODENAL STENOSIS. DURING STENT DEPLOYMENT, THE SHEATH DID NOT OPEN PROPERLY AND DEPLOYMENT OF THE STENT COULD NOT BE CONTROLLED. THE STENT WAS ACCIDENTALLY DEPLOYED DISTAL TO THE DUODENAL STENOSIS. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED AND THE LOCATION OF THE STENT DOES NOT HAVE ANY CLINICAL SIGNIFICANCE. 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 Consequences Or Impact To Patient

  MAUDE report 7529691 ↗