Cook G26927Recalls & 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 00827002269279), received between Aug 31, 2017 and Aug 31, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
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.
InjuryAug 31, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE BLUE LUMEN PORTION OF A DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER WAS LEAKING AFTER IMPLANTATION. THE CUSTOMER CONFIRMED THAT ONLY THE BLUE LUMEN WAS AFFECTED, AS THE WHITE LUMEN DID NOT LEAK WHEN USED. THE CUSTOMER HAD CONCERNS REGARDING POTENTIAL CONTAMINATION. ANOTHER CENTRAL LINE NEEDED TO BE PLACED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN.
Patient problems: No Code Available
MAUDE report 6835069 ↗
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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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