CXI G18372Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002183728), received between Dec 7, 2017 and Jun 5, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS ORIGINALLY REPORTED, DURING A RUN-OFF ANGIOGRAM OF THE RIGHT LEG, A WIRE WAS DIFFICULT TO ADVANCE THROUGH A CXI SUPPORT CATHETER, WHICH WAS ALSO DIFFICULT TO FLUSH. ACCESS WAS OBTAINED IN THE SUPERFICIAL FEMORAL ARTERY TO TARGET THE PERONEAL ARTERY. THE ANATOMY WAS CALCIFIED. THE HYDROPHILIC COATING WAS ACTIVATED, AND THE PHYSICIAN USED THE CATHETER ONE TIME. WHEN THE USER ATTEMPTED TO RE-USE THE CATHETER FOR A SECOND INSERTION, THE CATHETER WAS UNABLE TO BE FLUSHED, AND AN UNSPECIFIED WIRE WOULD NOT ADVANCE THROUGH THE CATHETER. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, AN UNKNOWN PIECE OF FOREIGN MATTER WAS INSIDE THE DISTAL TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467068 ↗
• MalfunctionDec 16, 2022Break; Break

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER WAS NOTED TO BE SEPARATED WHEN THE USER PULLED THE CATHETER FROM THE SPIRAL HOLDER. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE HAD BEEN STORED VERTICALLY AT THE USER FACILITY AND THE PACKAGE WAS NOT DAMAGED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997330 ↗
• MalfunctionNov 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322725 ↗
• InjuryDec 7, 2017Material Separation; Fitting Problem; Material Separation; Fitting Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CXI SUPPORT CATHETER HUB BROKE OFF DURING REMOVAL OF THE DEVICE AND CATHETER TUBING SEPARATED. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS THE PATIENT'S CHRONIC TOTAL OCCLUSION (CTO) FROM AN UP AND OVER APPROACH, THEN PROCEEDED TO GAIN ACCESS FROM THE DORSALIS PEDIS USING A PEDAL MICROPUNCTURE AND TRIED TO CROSS THE CTO RETROGRADE. A 25 GAUGE APPROACH CTO MICROGUIDE WIRE WITHOUT THE PEDAL SHEATH, USING THE CXI SUPPORT CATHETER OVER THE MIRCROGUIDE WIRE, WAS USED TO SUCCESSFULLY CROSS THE CTO WITH NOTED DIFFICULTLY. THE MICROGUIDE WIRE WAS ADVANCED THROUGH THE CTO, AND AS THE PHYSICIAN ATTEMPTED TO REMOVE THE CXI SUPPORT CATHETER IT FELT STUCK TO THE MICROGUIDE WIRE, PROMPTING HIM TO FORCIBLY PULL ON THE CATHETER HUB. THE CATHETER HUB COMPLETELY BROKE OFF OF THE CATHETER, AND THE PHYSICIAN ATTEMPTED REMOVAL OF THE CATHETER WITHOUT THE HUB BY PULLING ON IT FOR 20- 30 MINUTES. THE CATHETER WAS ABLE TO BE COMPLETELY REMOVED; HOWEVER IT BROKE INTO PIECES DURING REMOVAL OVER THE MICROGUIDE WIRE AS THE PHYSICIAN HAD TO USE FORCE IN ORDER TO MAINTAIN WIRE ACCESS. THE MICROGUIDE WIRE WAS SNARED FROM THE UP AND OVER APPROACH, AS INITIALLY INTE

  Patient problems: No Code Available

  MAUDE report 7095348 ↗