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CXI G18370Recalls & reported problems

Cook Incorporated · CXI Support Catheter · 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 00827002183704), received between Jun 21, 2018 and Feb 8, 2023 — classified as 2 malfunctions.

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
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 8, 2023Break; Break

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16322018 ↗
  • MalfunctionJun 21, 2018Material Separation; Material Separation

    IT WAS REPORTED, PRIOR TO PATIENT CONTACT, A SMALL PIECE OF THE CXI SUPPORT CATHETER'S DISTAL TIP BROKE OFF BEFORE LOADING ONTO THE WIRE. THE PROCEDURE WAS PERFORMED USING ANOTHER CATHETER. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7624879 ↗

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.