Cook G23259Recalls & reported problems
Cook Incorporated · Central Venous Tray Triple Lumen Polyurethane Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002232594), received between Aug 31, 2017 and Aug 31, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Crack” (2 reports).
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
- Crack2
- Fluid/Blood Leak1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2017Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT, 8 DAYS AFTER IMPLANTATION OF THE TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER, IT HAD TO BE REMOVED AND REPLACED BECAUSE IT WAS DISCOVERED THAT THE BLUE LUMEN WAS CRACKED. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE TO REPLACE THE CENTRAL LINE.
Patient problems: No Code Available
MAUDE report 6834732 ↗InjuryAug 31, 2017Crack; Crack
THE CUSTOMER REPORTED THAT, FOLLOWING THE PLACEMENT OF A DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER DURING A CENTRAL LINE PLACEMENT PROCEDURE, IT WAS DISCOVERED THAT THE WHITE HUB WAS CRACKED. THE CATHETER WAS REMOVED, AND A NEW ONE WAS PLACED. THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6834506 ↗
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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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