WallFlex™ Duodenal M00555860Recalls & reported problems
Boston Scientific Corporation · Stent System with Anchor Lock Delivery System · Class 2 · Implant
All models of WallFlex Duodenal (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729902492), received between Jun 23, 2022 and Jul 27, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Migration1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2023Migration; Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6)2023 THAT A WALLFEX DUODENAL UNCOVERED STENT WAS IMPLANTED TO TREAT A GASTRODUODENAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6)2023. ON (B)(6) 2023, POST STENT PLACEMENT, IT WAS NOTED THAT THE STENT HAD MIGRATED. THERE ARE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17410800 ↗InjuryJun 23, 2022Premature Activation; Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX DUODENAL STENT WAS TO BE IMPLANTED IN THE FIRST PART OF THE DUODENUM TO TREAT A 10 MM OVER 2 CM MALIGNANT DUODENAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, WHEN THE WALLFLEX DUODENAL STENT DELIVERY SYSTEM WAS DEPLOYED HALFWAY, THERE WAS NO MOVEMENT OF THE OUTER SHEATH THAT RELEASES THE STENT. THEN THE WALLFLEX DUODENAL STENT SUDDENLY DEPLOYED PREMATURELY. THE STENT WAS REMOVED FROM THE PATIENT WITH THE USE OF RESCUE COMBO FORCEPS. ANOTHER WALLFLEX DUODENAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14786571 ↗
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 M00555870Boston Scientific Corporation · Stent, metallic, expandable, duodenal1 death2 reports
- HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) DNJF-22-120-230M.I.Tech Co., Ltd. · Stent, Metallic, Expandable, Duodenal1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page