Evolution G23124Recalls & reported problems
Cook Ireland Ltd · EVOLUTION BILIARY, STENT SYSTEM - UNCOVERED · Class 2 · Implant
All models of Evolution (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002231242), received between Jul 11, 2023 and Jul 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Damaged Prior to Use1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-SEPT-2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17298458 ↗MalfunctionJul 11, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
CORRECTION REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION BEING RECEIVED ON THE 29-AUG-23, RESULTING IN AN UPDATE TO THE RPN FROM EVO-8-9-8-B TO EVO-8-9-6-B.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17296588 ↗
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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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