Oasis G26853Recalls & 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 00827002268531), received between Jul 23, 2019 and Jul 23, 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
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.
MalfunctionJul 23, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
INTRODUCER HUB OF OATS-8.5-12/ LOT C1563536 CAME OFF. [UPDATED ON 27/JUNE/2019 (B)(4)] ERCP & STENT EXCHANGE WERE PERFORMED. PRE-EXISTING OATS-8.5-12 WAS REMOVED WITH A FORCEPS. THEN, CANNULATION WAS PERFORMED AND BOSTON SCIENTIFIC'S JAGWIRE 0.035" WAS ADVANCED TO THE BILE DUCT. AFTER THAT, OATS-8.5-12/ LOT C1563536 WAS ADVANCED OVER THE WIRE GUIDE. THE STENT REACHED PROPER POSITION TO PLACE AND THEN THE USER DISCONNECTED LUER LOCK FITTING ON THE INTRODUCER AND ADVANCED THE POSITIONING SLEEVE BUT THE USER FELT SOME RESISTANCE. HE CHECKED THE ELEVATOR OF THE ENDOSCOPE AND CONFIRMED IT IN THE DOWN POSITION. THEREFORE HE CONTINUED ADVANCING THE POSITIONING SLEEVE WITH HOLDING THE INTRODUCER FITTING BUT THE FITTING CAME OFF DURING THE ADVANCEMENT. HE HOLDED THE INTRODUCER SHAFT WITH HIS HAND AND PLACED THE STENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 8815957 ↗
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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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