WallFlex™ Colonic M00565150Recalls & reported problems
Boston Scientific Corporation · Stent System with Anchor Lock Delivery System · Class 2 · Implant
Data updated Oct 13, 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 08714729456629), received between May 29, 2025 and May 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
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.
MalfunctionMay 29, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE SIGMOID COLON TO TREAT A MALIGNANT STRICTURE DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WOULD NOT FULLY DEPLOY FROM THE CATHETER. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS NOT COMPLETED AS NO ADDITIONAL DEVICE OF THE SAME TYPE WAS AVAILABLE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104489 ↗
Other STENT, COLONIC, METALIC, EXPANDABLE devices
- WallFlex™ Colonic M00565050Boston Scientific Corporation · STENT, COLONIC, METALIC, EXPANDABLE2 deaths63 reports
- Evolution G48028Cook Ireland Ltd · STENT, COLONIC, METALIC, EXPANDABLE45 reports
- Evolution G48038Cook 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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