CXI G23863Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002238633), received between Jan 2, 2020 and Jan 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 2, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER LEAKED AND WAS LATER FOUND TO BE CRACKED. ACCESS WAS OBTAINED MIDWAY DOWN THE RIGHT ANTERIOR TIBIAL ARTERY TO REACH THE DORSALIS PEDIS ARTERY. A COOK APPROACH HYDRO ST MICROWIRE WIRE GUIDE WAS USED WITH THE DEVICE. THE DIABETIC PATIENT'S ANATOMY WAS SEVERELY CALCIFIED AND THE VESSELS WERE SMALL. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF THE DEVICE, AND FORTY-FIVE MINUTES INTO THE PROCEDURE, THE WIRE GUIDE AND THE CXI BECAME "BALLED UP". AS THE DEVICES WERE BEING REMOVED, APPROXIMATELY TWO MILLIMETERS OF THE WIRE GUIDE SEPARATED IN THE PATIENT BY THE ANTERIOR ARTERY REGION. THIS WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). A NEW WIRE WAS INSERTED AND THE PROCEDURE WAS CONTINUED. THE PHYSICIAN THEN NOTICED THAT THE CXI WAS LEAKING AND THE DEVICE WAS REMOVED, AT WHICH TIME THE CXI WAS FOUND TO BE CRACKED DOWN THE SHAFT. ANOTHER COOK CATHETER WAS THEN INTRODUCED BUT THE LESION WAS UNABLE TO BE CROSSED. THE PHYSICIAN WAS ABLE TO OPEN TWO VESSELS, BUT NOT THE ANTERIOR VESSELS. THERE ARE NO FURTHER PROCEDURES SCHEDULED AT THIS TIME. A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538051 ↗