CXI G18371Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002183711), received between Jul 18, 2016 and Sep 30, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951625 ↗
• MalfunctionMar 9, 2022Break; Material Separation; Break; Material Separation

  AS REPORTED, WHILE PLACING A CXI SUPPORT CATHETER OVER A WIRE THE RADIOPAQUE TIP OF THE SUPPORT CATHETER SEPARATED FROM THE REST OF THE DEVICE. THE TARGET ACCESS SITE WAS THE GROIN, AND WE WERE USING A HYDRO ST. THE MARKER SEPARATED WHILE ON THE WIRE. THE DEVICE DID NOT MAKE PATIENT CONTACT. WHEN THE USER NOTICED THE ISSUE, THEY REMOVED THE CATHETER AND REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713910 ↗
• MalfunctionOct 18, 2021Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, DURING A BELOW-THE-KNEE TREATMENT PROCEDURE VIA IPSILATERAL APPROACH FROM THE RIGHT FEMORAL ARTERY, ANOTHER MANUFACTURER'S WIRE WOULD NOT ADVANCE THROUGH THE HUB OF A CXI SUPPORT CATHETER. THE TIP OF THE WIRE WAS INSERTED THROUGH THE HUB, BUT THE WIRE WOULD NOT PASS. THE WIRE GUIDE TIP WAS ALTERED BY THE USER PRIOR TO INSERTION INTO THE CATHETER. A WIRE INSERTER WAS NOT USED. ANOTHER CXI DEVICE OF A DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON INVESTIGATION OF THE RETURNED DEVICE, A HOLE WAS NOTED IN THE SHAFT OF THE CATHETER, AND AN UNKNOWN BLUE AND GREEN SUBSTANCE WAS FLUSHED FROM THE HUB OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646785 ↗
• MalfunctionOct 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9139515 ↗
• MalfunctionAug 6, 2019Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864214 ↗
• MalfunctionApr 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550345 ↗
• MalfunctionMar 7, 2017Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED, THE CXI SUPPORT CATHETER WAS NOTICED TO BE STICKY AFTER BEING LOADED ONTO THE WIRE. THE CATHETER WAS REMOVED AND THE MARKER BAND TIP OF THE CATHETER CAME OFF AND REMAINED STUCK ON THE WIRE. THIS OCCURRED BEFORE PATIENT CONTACT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6383650 ↗
• InjuryJul 18, 2016Break; Break

  THE PHYSICIAN TRIED TO DILATE A TOTAL OCCLUSION OF AN ANTERIOR TIBIAL ARTERY ANEURYSM (ATA). THE PHYSICIAN COULD NOT FIND A WAY THROUGH THE HEAVILY CALCIFIED ATA FROM ANTEGRAD, SO THE PHYSICIAN TRIED TO RETROGRAD FROM THE PEDAL. THIS WAS SUCCESSFUL. A TUNNEL WAS FOUND WITH THE WIRE, BUT COULD NOT MOVE FORWARD WITH ANY BALLOON. WHEN THE PHYSICIAN TRIED TO PULL BACK THE PRODUCT, THE TIP OF IT GOT STUCK IN THE HEAVY CALCIFICATION. THE CATHETER WAS PULLED STRONGLY, AND THE TIP TORE OFF AND REMAINS STUCK IN THE CALCIFICATION. ALL ATTEMPTS TO CAPTURE THE PEAK WERE UNSUCCESSFUL. THE PHYSICIAN DID NOT SEE A PROBLEM IN LEAVING THE TIP. THE VESSELS ARE OCCLUDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5802129 ↗