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CXI G18378Recalls & reported problems

Cook Incorporated · CXI Support Catheter · Class 2

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 00827002183780), received between Jun 22, 2023 and Jun 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 22, 2023Break; Break

    ADDITIONAL INFORMATION RECEIVED 01AUG2023. THE CATHETER WAS BEING ADVANCED ONTO ANOTHER MANUFACTURER'S WIRE OUTSIDE THE PATIENT WHEN THE TIP SEPARATION OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SAME TYPE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17182668 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

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