Oasis G26849Recalls & reported problems
Cook Ireland Ltd · Oasis One Action Stent Introduction System, with Pre-Loaded ST-2 Tannenbaum 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 00827002268494), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2018Difficult to Advance; Difficult to Advance
IT WAS UNABLE TO RELEASE THE STENT IN THE BILE DUCT, SO THE USER REPLACED IT WITH OTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE. REPORTING DUE TO THE PRECEDENCE FOR "DIFFICULT TO ADVANCE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7377563 ↗
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- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
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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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