Oasis G25383Recalls & 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 00827002253834), received between Aug 26, 2019 and Aug 26, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Difficult to Advance1
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.
MalfunctionAug 26, 2019Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance
A MALE PATIENT UNDERWENT A PROCEDURE TO PLACE 1 OASIS ONE ACTION STENT, G25383, TO DRAIN AN ABSCESS IN THE UPPER HEPATIC DUCT. THE PRE-LOADED PLASTIC STENT WAS PLACED INTO THE ABSCESS AT WHICH POINT THE DR. ASKED MYSELF AND MY REGIONAL MANGER MATTHEW HENDERSON IF WE CHANGED HOW WE MADE OUR STENTS? ONCE WE LOOKED CLOSER AT THE PLACED STENT IT WAS CLEAR THAT IT WAS IN BACKWARDS AND THAT IT WAS PACKAGED PRELOADED ONTO THE INTRODUCER BACKWARDS (PR272880). THE STENT, ALTHOUGH BACKWARDS, WAS COMPLETING DRAINAGE AS NEEDED AND NO FURTHER ACTION WAS TAKEN. THE STENT WAS LEFT IN THE PATIENT AND COMPLICATIONS WERE NOT EXPECTED, WE SIMPLY NEED TO POINT OUT THE ASSEMBLY ERROR TO FURTHER MAKE SURE THIS ISN'T HAPPENING MORE OFTEN THAN NOT. THE DOCTOR DID STATE THAT HE HAS SEEN THIS BEFORE (PR273723), HOWEVER HE HAD BLAMED THE FELLOW PLACING THE STENT NOT REALIZING IT WAS PRELOADED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8930759 ↗
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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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