CXI G18369Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002183698), received between Apr 15, 2022 and Dec 16, 2022 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionDec 16, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED 24JAN2023. THE TARGET LOCATION WAS THE ANTERIOR TIBIAL ARTERY VIA PEDAL ACCESS. THE PATIENT'S ANATOMY WAS CALCIFIED AND ANOTHER MANUFACTURER'S SHEATH WAS USED DURING THE PROCEDURE. UPON REMOVAL OF THE CXI OVER THE WIRE, RESISTANCE WAS FELT AS THE CXI WAS "STUCK" ON THE WIRE. THE SEPARATED TIP WAS REMOVED OVER THE WIRE. A POWER INJECTOR WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998605 ↗
• MalfunctionApr 15, 2022Break; Break

  AS REPORTED, AT THE BEGINNING OF A PROCEDURE INVOLVING THE POSTERIOR TIBIAL TRUNK VIA POSTERIOR TIBIAL ACCESS, THE DISTAL TIP OF A CXI SUPPORT CATHETER SEPARATED INSIDE THE PATIENT. AN UNSPECIFIED COOK PEDAL ACCESS KIT AND ANOTHER MANUFACTURER'S 0.014-INCH WIRE WERE ALSO USED DURING THE PROCEDURE. THE HYDROPHILIC COATING WAS ACTIVATED. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE DUE TO SEVERELY CALCIFIED ANATOMY. A POWER INJECTOR WAS NOT USED. THE SEPARATED PORTION OF THE CATHETER WAS REMOVED OVER THE WIRE GUIDE AND ANOTHER CXI CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120220 ↗