WALLSTENT™ Enteral Endoprosthesis M00565570Recalls & reported problems
Boston Scientific Corporation · Colonic/Duodenal Stent with UNISTEP™ Plus Delivery System · Class 2 · Implant
All models of WALLSTENT Enteral Endoprosthesis (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729285069), received between Dec 7, 2023 and Dec 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Puncture/Hole1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other STENT,METALLIC,EXPANDABLE,DUODENAL devices
- Evolution G48026Cook Ireland Ltd · STENT,METALLIC,EXPANDABLE,DUODENAL1 death57 reports
- WallFlex™ Duodenal M00565020Boston Scientific Corporation · STENT,METALLIC,EXPANDABLE,DUODENAL42 reports
- WallFlex™ Duodenal M00565030Boston Scientific Corporation · STENT,METALLIC,EXPANDABLE,DUODENAL2 deaths38 reports
- WallFlex™ Duodenal M00565010Boston Scientific Corporation · STENT,METALLIC,EXPANDABLE,DUODENAL1 death30 reports
- Evolution G48027Cook Ireland Ltd · STENT,METALLIC,EXPANDABLE,DUODENAL30 reports
- Evolution G48025Cook Ireland Ltd · STENT,METALLIC,EXPANDABLE,DUODENAL14 reports
- WallFlex™ Duodenal M00555860Boston Scientific Corporation · Stent, metallic, expandable, duodenal2 reports
- WallFlex™ Duodenal M00555870Boston Scientific Corporation · Stent, metallic, expandable, duodenal1 death2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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