Cook G02058Recalls & 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 00827002020580), received between Apr 18, 2025 and Apr 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
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.
InjuryApr 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE CATHETER INCLUDED IN THE FEMORAL ARTERY PRESSURE MONITORING SET FRACTURED AT THE HUB. UPON ARRIVAL IN THE ICU POST-SURGERY, IT WAS NOTED THAT THE FEMORAL ARTERIAL LINE HAD BEEN SHEARED OFF. THE SURGEON WAS PROMPTLY NOTIFIED, AND THE PATIENT WAS TRANSFERRED TO THE CARDIOVASCULAR INTERVENTIONAL LABORATORY (CVIL) FOR REMANGIOGRAPHY. ON (B)(6) 2025, THE PATIENT WAS RECEIVED IN CVIL FOLLOWING AN OFF-PUMP CORONARY ARTERY BYPASS GRAFTING (OPCABCG) PROCEDURE INVOLVING THREE GRAFTS. THE FEMORAL CANNULA WAS IN SITU IN THE LEFT FEMORAL ARTERY AND SUTURED TO THE SKIN. THE RIGHT GROIN WAS BRUISED AND SHOWED SIGNS OF HEMATOMA FROM A CORONARY ANGIOGRAM PERFORMED ON (B)(6)2025. THE PATIENT WAS INTUBATED AND VENTILATED. AN ULTRASOUND OF THE LEFT GROIN REVEALED A FOREIGN BODY, WHICH WAS VISIBLE ON THE ULTRASOUND-GUIDED ACCESS. A 4FR SHEATH WAS INITIALLY INSERTED INTO THE RIGHT FEMORAL ARTERY (RFA), WHICH WAS LATER UPGRADED TO A 6FR 45CM SHEATH. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED USING A SNARE. POST-ANGIOGRAPHY REVEALED TRAUMA TO THE VESSEL, BUT THERE WAS NO BLEEDING FROM THE RIGHT GROIN. A COMPETITOR DEVICE (5FR) WAS USED TO CLOSE THE RIGHT GROIN. THE PATIENT WAS TH
Patient problems: Foreign Body In Patient
MAUDE report 21866136 ↗
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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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