CXI G18367Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002183674), received between Apr 24, 2018 and Aug 30, 2018 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionAug 30, 2018Material Perforation; Material Perforation

  IT WAS REPORTED, ANOTHER MANUFACTURER'S GUIDEWIRE PERFORATED THROUGH THE SIDE OF THE CXI SUPPORT CATHETER DURING ANGIOPLASTY OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE COMPLAINT DEVICE WAS BEING USED FROM THE DISTAL SFA IN A RETROGRADE MANNER TO CROSS THE OCCLUSION. IT IS NOT KNOWN AT WHAT POINT IN THE PROCEDURE THE COMPLAINT DEVICE WAS PERFORATED BECAUSE IT WASN'T DISCOVERED UNTIL IT'S REMOVAL FROM THE PATIENT'S ANATOMY. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO HARM TO THE PATIENT OR ADDITIONAL PROCEDURE REQUIRED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7834508 ↗
• InjuryApr 24, 2018Kinked; Kinked

  IT WAS REPORTED THAT THE 0.018 HYDROPHILIC WIRE UTILIZED THROUGH THE CXI SUPPORT CATHETER KINKED WHILE INSIDE THE PATIENT'S VASCULATURE AND REQUIRED A SURGICAL INTERVENTION TO REMOVE IT. ACCESS WAS GAINED VIA THE PEDAL ARTERY. AS THE PHYSICIAN WAS TRYING TO ADVANCE THE WIRE THROUGH THE HEAVILY CALCIFIED, NARROWED, POPLITEAL ARTERY LESION, IT KINKED. ADDITIONAL ATTEMPTS USING OTHER CXI SUPPORT CATHETER SIZES WERE UNSUCCESSFUL DUE TO THE HEAVY CALCIFICATION OF THE LESION; THEREFORE, THE PROCEDURE WAS ABORTED. NO OTHER DEVICE MALFUNCTIONS WERE REPORTED. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO ADDITIONAL ADVERSE EFFECT WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 7454684 ↗