Cook G02179Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002021792), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Fracture1
- Material Split, Cut or Torn1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2019Fluid/Blood Leak; Fracture; Material Split, Cut or Torn; Fluid/Blood Leak; Fracture; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER IN A FEMORAL ARTERY PRESSURE MONITORING SET WAS FOUND TO BE BROKEN AND LEAKING. THE PROCEDURE PERFORMED ON THE PATIENT WAS A FEMORAL ARTERY CANNULATION. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. AS REPORTED, THERE WERE NO ADVERSE EFFECTS EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9310340 ↗
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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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