Cook G25092Recalls & reported problems
Cook Ireland Ltd · Pushing Catheter · Class 2
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 00827002250925), received between Nov 30, 2018 and Nov 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device 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.
MalfunctionNov 30, 2018Use of Device Problem; Use of Device Problem
AS REPORTED TO CUSTOMER RELATIONS "THE PUSHER WAS INTRODUCED OVER A .018 WIRE (BOSTON SCIENTIFIC NOVA GOLD) TO PUSH A STENT. AS THEY WERE PULLING THE PUSHER OUT IT, WAS COILING ON THE WIRE. IT WAS NOT COMING OUT SMOOTHLY AND THE MATERIAL WAS BUNCHING UP. THEY WERE ABLE TO EVENTUALLY GET THE PUSHER PULLED OUT ALONG WITH THE WIRE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8119026 ↗
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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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