Cook G26934Recalls & reported problems
Cook Incorporated · Central Venous Tray Double Lumen Polyurethane Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002269347), received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED A DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS FOUND LEAKING AT THE BLUE HUB SHORTLY AFTER PLACEMENT. THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY DURING AN ADDITIONAL PROCEDURE. ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION IS UNKNOWN. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 7922860 ↗
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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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