WALLSTENT® Endoprosthesis H965404510Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent · Class 2 · Implant
All models of WALLSTENT Endoprosthesis (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729204138), received between Sep 16, 2021 and Oct 18, 2023 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Unsealed Device Packaging1
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.
MalfunctionOct 18, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25SEP2023. IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS OCCLUDED WITH TUMOR COMPRESSION LOCATED IN THE SUPERIOR VENA CAVA. A 22X45/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ATTEMPTED TO DEPLOY THE STENT, RESISTANCE WAS ENCOUNTERED, AND FOUND THE SHAPE OF THE STENT WAS NOT GOOD AND THE TIP COULD NOT BE FULLY OPENED. THE PROCEDURE WAS COMPETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE REVEALED STENT WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17957779 ↗MalfunctionSep 16, 2021Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE DEVICE PACKAGING WAS DAMAGED. A 22X45/10FR WALLSTENT UNI STENT WAS SELECTED FOR USE. HOWEVER, UPON INSPECTION, IT WAS NOTED THAT THE OUTER PACKAGE AND THE INNER PACKAGE CONTAINING THE STENT WERE DAMAGED. THE DEVICE WAS UNUSABLE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12485822 ↗
Other Prosthesis, tracheal, expandable devices
- iCAST 85453Atrium Medical Corporation · Prosthesis, tracheal, expandable43 reports
- WALLSTENT™ BILIARY H965430500Boston Scientific Corporation · Prosthesis, tracheal, expandable13 reports
- iCAST 85419Atrium Medical Corporation · Prosthesis, tracheal, expandable13 reports
- iCAST 85445Atrium Medical Corporation · Prosthesis, tracheal, expandable12 reports
- iCAST 85416Atrium Medical Corporation · Prosthesis, tracheal, expandable12 reports
- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
- iCAST 85455Atrium Medical Corporation · Prosthesis, tracheal, expandable11 reports
- iCAST 85414Atrium Medical Corporation · Prosthesis, tracheal, expandable10 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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