CXI G56552Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002565524), received between Nov 5, 2020 and Jan 16, 2026 — classified as 2 injuries, 6 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.

• MalfunctionJan 16, 2026Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED PRIOR TO PATIENT CONTACT AS IT WAS INSERTED INTO A SHEATH AND ADVANCED OVER A WIRE GUIDE. A NEW CXI CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093397 ↗
• InjuryDec 30, 2025Break; Break

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, THE TIP OF A CXI SUPPORT CATHETER SEPARATED INSIDE OF THE PATIENT. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL ARTERY AND PROFUNDA. ANOTHER MANUFACTURER¿S SHEATH AND ANOTHER MANUFACTURER¿S WIRE WERE USED DURING THE PROCEDURE. THE HYDROPHILIC COATING WAS REPORTEDLY ACTIVATED. RESISTANCE WAS ENCOUNTERED DURING INSERTION/ADVANCEMENT OF THE CATHETER, AS THE LESION WAS CALCIFIED. DURING REMOVAL OF THE OTHER MANUFACTURER¿S 0.014-INCH WIRE GUIDE, THE TIP OF THE CATHETER SEPARATED ¿FROM THE DISTAL MARKER FORWARD¿. PER THE REPORTER, IT IS UNCLEAR IF THE WIRE WAS PULLED FIRST OR IF THE CATHETER WAS PULLED WITH THE WIRE INSIDE. A POWER INJECTOR WAS NOT USED WITH THE CATHETER. THE USER WAS UNABLE TO CROSS THE LESION; THEREFORE, THE PROCEDURE WAS NOT COMPLETED. THE SEPARATED FRAGMENT REMAINS IN THE PATIENT, WITHIN A LATERAL BRANCH OF THE PROFUNDA. PER THE REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23926754 ↗
• InjuryNov 4, 2025Break; Break

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

  Patient problems: Foreign Body In Patient

  MAUDE report 23468789 ↗
• MalfunctionDec 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED BY A DISTRIBUTOR, FOREIGN MATTER WAS NOTED IN A CXI SUPPORT CATHETER'S STERILE PACKAGE. THERE WERE NO ADVERSE EFFECTS TO ANY PATIENT. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929649 ↗
• MalfunctionJul 14, 2022Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A WIRE CAME OUT OF A HOLE IN THE SIDE OF A CXI SUPPORT CATHETER. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE DISTAL TIP WAS NOTED TO BE PARTIALLY SEPARATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15012885 ↗
• MalfunctionDec 16, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017440 ↗
• MalfunctionAug 20, 2021Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  AS REPORTED, AN UNKNOWN SUBSTANCE WAS ATTACHED TO A CXI SUPPORT CATHETER PRIOR TO USE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A DARK, STRING-LIKE SUBSTANCE, WHICH APPEARS TO BE ATTACHED TO THE HUB OF THE DEVICE. 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 12349029 ↗
• MalfunctionNov 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795613 ↗