Cook G51531Recalls & reported problems
Cook Incorporated · Central Venous Catheter Set 5 Lumen Polyurethane · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002515314), received between Sep 25, 2017 and Sep 25, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionSep 25, 2017Break
WHEN THE PHYSICIAN WAS OPENING THE PACKAGE, HE OBSERVED THAT THE CATHETER WAS BROKEN, AND THIS OCCURRED WITH FOUR DIFFERENT LOT NUMBERS. THE PHYSICIAN MANAGED TO USE A FIFTH PRODUCT TO FINISH THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6892161 ↗MalfunctionSep 25, 2017Break
WHEN THE PHYSICIAN WAS OPENING THE PACKAGE, HE OBSERVED THAT THE CATHETER WAS BROKEN, AND THIS OCCURRED WITH FOUR DIFFERENT LOT NUMBERS. THE PHYSICIAN MANAGED TO USE A FIFTH PRODUCT TO FINISH THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6892023 ↗
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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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