Cook G26937Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002269378), received between Nov 27, 2018 and Dec 19, 2019 — classified as 1 injury, 1 malfunction.
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
- Fracture1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2019Crack; Fracture; Crack; Fracture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9494709 ↗InjuryNov 27, 2018Crack; Crack
IT WAS REPORTED THE BLUE HUB ON A DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER PLACED ON (B)(6) 2018 WAS FOUND CRACKED ON (B)(6) 2018. THE LINE WAS IN SITU FOR 15-HOURS AND REPLACED WITH A LIKE DEVICE DURING AN ADDITIONAL PROCEDURE. THE DEVICE WAS CONNECTED TO A SMARTSITE NEEDLE FREE VALVE. A 70% ALCOHOL SWAB WAS USED TO SCRUB THE HUB AND IT WAS ALLOWED TO COMPLETED DRY BEFORE A NEW NEEDLELESS CONNECTOR (NC) WAS PLACED. NC CHANGES HAD BEEN COMPLETED AT 0400 FOR BLOOD CULTURES. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 8108665 ↗
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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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