Cook G02598Recalls & reported problems
Cook Incorporated · Femoral Artery 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 00827002025981), received between Oct 6, 2022 and Oct 6, 2022 — 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
- Detachment of Device or Device Component1
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.
InjuryOct 6, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER IN FEMORAL ARTERY PRESSURE MONITORING SET THAT EXPIRED ON 05JAN2022 SEPARATED. THE EXPIRED FEMORAL ARTERY LINE WAS USED AS A SINGLE LUMEN CENTRAL VENOUS CATHETER. AFTER PLACEMENT, THE LINE SNAPPED AT THE HUB, AND 8 CM OF THE CATHETER WAS LEFT IN THE PATIENT. THE PATIENT SUBSEQUENTLY HAD TO GO TO INTERVENTIONAL RADIOLOGY TO HAVE IT REMOVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 15555461 ↗
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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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