Cook G02926Recalls & reported problems
Cook Incorporated · Radial Artery Catheter Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002029262), received between Jul 8, 2019 and Feb 2, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product2
- Material Separation2
Patient problems
- Foreign Body In Patient2
- No Patient Involvement2
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2022Material Separation; Material Separation
IT WAS REPORTED THAT A CATHETER INCLUDED IN THE RADIAL ARTERY PRESSURE MONITORING SET BROKE WHILE IMPLANTED IN THE PATIENT. A CUT DOWN WAS REQUIRED TO REMOVE THE SECTION OF SEPARATED CATHETER FROM THE RADIAL ARTERY. THE DEVICE IS NOT AVAILABLE FOR RETURN, AS IT WAS THROWN AWAY IN THE OPERATING ROOM. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 13429512 ↗InjuryApr 15, 2020Material Separation; Material Separation
NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 9964888 ↗MalfunctionJul 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8768401 ↗MalfunctionJul 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8768352 ↗
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- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
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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