WALLSTENT™ Enteral Endoprosthesis M00565650Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729285144), received between Oct 19, 2017 and Oct 19, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2017Break; Positioning Problem; Break; Positioning Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLSTENT ENTERAL UNCOVERED STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A 4 CM MALIGNANT STRICTURE OF THE PYLORUS DUE TO COMPRESSION BY A PANCREATIC MASS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DEPLOY THE STENT IN THE FRONT PORTION OF THE DUODENUM. HOWEVER, THE STENT MIGRATED INTO THE DUODENUM AND AWAY FROM THE STOMACH. THE PHYSICIAN USED BIOPSY FORCEPS AND RAT TOOTH FORCEPS TO TRY TO REPOSITION THE STENT BUT THE ENDS OF THE STENT BECAME UNDONE. THE STENT MIGRATED FURTHER INTO THE DUODENUM AND THE PHYSICIAN USED FORCEPS TO PULL THE STENT BACK UP INTO THE STOMACH, WHICH CAUSED MORE STENT WIRES TO BREAK. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO REMOVE THE BROKEN 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 FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6963398 ↗
Other STENT, COLONIC, METALIC, EXPANDABLE devices
- WallFlex™ Colonic M00565050Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE2 deaths63 reports
- Evolution G48038Cook Ireland Ltd · STENT, COLONIC, METALIC, EXPANDABLE45 reports
- Evolution G48028Cook Ireland Ltd · STENT, COLONIC, METALIC, EXPANDABLE45 reports
- WallFlex™ Colonic M00565060Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE2 deaths33 reports
- WallFlex™ Colonic M00565040Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE1 death23 reports
- WALLSTENT™ Enteral Endoprosthesis M00565590Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE15 reports
- WallFlex™ Colonic M00565110Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE3 deaths14 reports
- WallFlex™ Colonic M00565120Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE11 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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