Oasis G25659Recalls & reported problems
Cook Ireland Ltd · Oasis One Action Stent Introduction System, with Pre-Loaded Cotton Leung Biliary Stent · Class 2 · Implant
All models of Oasis (15)
Data updated Oct 16, 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 00827002256590), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation
THE STENT WAS TOO SOFT TO ACCESS THE PAPILLA THAT THE STENT KINKING AFTERWARDS. THE STENT FELL INTO THE DUODENUM WHEN THE PHYSICIAN WITHDREW IT. AS A RESULT, THE PHYSICIAN USED BOSTON'S STENT INSTEAD.
Patient problems: Failure of Implant
MAUDE report 8149909 ↗
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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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