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Cook G09435Recalls & reported problems

Cook Incorporated · High Pressure Connecting Tube · 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 00827002094352), received between May 1, 2018 and May 1, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component2
  • Fluid/Blood Leak1
  • Improper Flow or Infusion1

Patient problems

  • Blood Loss1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 1, 2018Detachment Of Device Component; Fluid/Blood Leak

    IT WAS REPORTED THAT THE CAP FROM THE HIGH PRESSURE TUBING CAME OFF, AND CONTRAST MEDIA AND BLOOD SPRAYED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7476755 ↗
  • MalfunctionMay 1, 2018Detachment Of Device Component; Improper Flow or Infusion

    IT WAS REPORTED THAT THE CAP FROM THE HIGH PRESSURE TUBING CAME OFF, AND CONTRAST MEDIA AND BLOOD SPRAYED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: Blood Loss

    MAUDE report 7476635 ↗

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.