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CXI G18368Recalls & reported problems

Cook Incorporated · CXI Support Catheter · Class 2

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 00827002183681), received between Jan 18, 2019 and Jan 18, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • Foreign Body In Patient1
  • No Code Available1

Recent adverse event reports

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

  • InjuryJan 18, 2019Material Separation; Material Separation

    IT WAS REPORTED, A (B)(6) YEAR OLD MALE UNDERWENT AN UNKNOWN PROCEDURE DURING WHICH A CXI SUPPORT CATHETER WAS USED. THE DISTAL TIP OF THE DEVICE BROKE OFF INSIDE OF THE PATIENT. A STENT WAS PLACED OVER THE PIECE THAT BROKE OFF AND SUTURED IN PLACE IN ORDER TO PREVENT MIGRATION. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Patient problems: Foreign Body In Patient; No Code Available

    MAUDE report 8260851 ↗

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.