Oasis G25657Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002256576), received between Feb 27, 2019 and Feb 27, 2019 — classified as 1 malfunction.
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
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2019Material Deformation; Material Deformation
AFTER PLACED THE STENT THE PHYSICIAN WITHDRAW THE PUSHING CATHETER, BUT HE FELT THE PUSHING CATHETER WAS SO TIGHT TO PULL OUT. THEREFORE, THE PHYSICIAN WITHDRAW IT WITH STRONG PULLING. AS A RESULT, THE PUSHING CATHETER WAS KINKING. THOUGH THE STENT WAS PLACED COMPLETED, THE PHYSICIAN CONSIDER THE PRODUCT'S QUALITY IS INFERIOR. FDA MDR REPORTING REQUIRED - REFERENCE (B)(4) ¿USE ERROR SITUATION: PHYSICIAN FAILS TO READ INSTRUCTIONS AND USES DEVICE DIFFERENTLY TO THE IFU¿ - OVERALL RISK ASSESSED AS CATEGORY IIB (MODERATE). NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. THE RISK IS NOT CONSIDERED TO BE 'REMOTE'.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8372928 ↗
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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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