Cook G01915Recalls & reported problems
Cook Incorporated · Central Venous Catheter Set · 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 00827002019157), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2018Break; Break
THE CUSTOMER REPORTED THAT THE LINE OF THE SINGLE LUMEN PRESSURE MONITORING SET SEVERED FROM THE HUB PORTION OF THE DEVICE, WHICH LED TO THE SEPARATED PART BECOMING LODGED IN THE PATIENT'S BLOOD VESSEL. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 7214297 ↗
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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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