Cook G24806Recalls & reported problems
Cook Incorporated · Central Venous Catheter Set Triple Lumen Polyurethane · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002248069), received between Sep 15, 2017 and Sep 26, 2017 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Defective Component” (9 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
- Defective Component9
- Unraveled Material7
- Defective Device2
- Difficult to Advance1
- Disassembly1
- Failure to Advance1
Patient problems
- No Known Impact Or Consequence To Patient12
- No Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2017Failure to Advance; Difficult to Advance
THE GUIDEWIRE IS STICKING ON INSERTION. THE CENTRAL VENOUS CATHETER WAS BEING INSERTED IN THE RIGHT SUBCLAVIAN. THE WIRE WOULD NOT GO THROUGH THE WIRE FEEDER SMOOTHLY, IT WAS GETTING CAUGHT AND NOT ADVANCING. PHYSICIAN HAD TO STOP PROCEDURE AND TRY A NEW TRAY. THE SECOND TRAY DIDN'T WORK EITHER. PROCEDURE WAS ABORTED. ALTERNATE LINES WERE ESTABLISHED. IT IS UNKNOWN IF THE PATIENT UNDERWENT ANY ADDITIONAL PROCEDURES.
Patient problems: No Information
MAUDE report 6895234 ↗MalfunctionSep 18, 2017Unraveled Material; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6871734 ↗MalfunctionSep 18, 2017Defective Device
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6871656 ↗MalfunctionSep 15, 2017Unraveled Material; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6870052 ↗MalfunctionSep 15, 2017Disassembly; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6870039 ↗MalfunctionSep 15, 2017Unraveled Material
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869998 ↗MalfunctionSep 15, 2017Unraveled Material; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869986 ↗MalfunctionSep 15, 2017Unraveled Material; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869970 ↗MalfunctionSep 15, 2017Unraveled Material; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869961 ↗MalfunctionSep 15, 2017Unraveled Material; Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869945 ↗MalfunctionSep 15, 2017Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869935 ↗MalfunctionSep 15, 2017Defective Device
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869901 ↗MalfunctionSep 15, 2017Defective Component
THE CUSTOMER STATED THAT THE GUIDE WIRE WAS DEFECTIVE AND IT UNRAVELED. THERE WERE NO REPORTED ADVERSE EFFECTS OR PATIENT HARM AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869863 ↗
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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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