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Cook G00065Recalls & reported problems

Cook Incorporated · Connecting Tube Female to Male Luer Lock · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002000650), received between May 1, 2018 and May 1, 2018 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Leak/Splash1

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 1, 2018Fluid/Blood Leak

    IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, A TECHNICIAN CONNECTED THE HIGH PRESSURE BRAIDED CONNECTING TUBE TO THE POWER INJECTOR AND IT WAS FOUND TO BE LEAKING. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Patient problems: No Patient Involvement

    MAUDE report 7475769 ↗
  • MalfunctionMay 1, 2018Leak/Splash

    IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, A TECHNICIAN CONNECTED THE HIGH PRESSURE BRAIDED CONNECTING TUBE TO THE POWER INJECTOR AND IT WAS FOUND TO BE LEAKING. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Patient problems: No Patient Involvement

    MAUDE report 7475215 ↗

Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.