CXI G56550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002565500), received between Feb 8, 2018 and May 22, 2025 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, PRIOR TO A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE CXI SUPPORT CATHETER'S PACKAGE WAS DISCOVERED TO BE UNSEALED WHEN THE USER ATTEMPTED TO OPEN IT. THE USER UTILIZED A NEW SAME TYPE OF DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068944 ↗
• MalfunctionMar 12, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A THIN STRAND OF PLASTIC CAME OFF THE SIDE OF A CXI SUPPORT CATHETER. THE CATHETER WAS REMOVED FROM THE PACKAGE, WHICH WAS NOT DAMAGED, AND WAS THEN FLUSHED AS NORMAL, WITHOUT DIFFICULTY. PRIOR TO ADVANCEMENT OF THE CATHETER OVER AN UNSPECIFIED WIRE GUIDE, THE CATHETER WAS INSPECTED, AND A THIN STRAND OF PLASTIC WAS NOTED TO COME FROM THE SIDE OF THE CATHETER, "ABOUT ONE-THIRD OF THE TOTAL LENGTH BACK FROM THE TIP". THE CATHETER WAS NEVER ADVANCED OVER THE WIRE. THE CATHETER WAS NOT USED AND NEVER ENTERED THE PATIENT. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. 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 18886520 ↗
• InjuryJun 27, 2023Break; 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 17209842 ↗
• MalfunctionMar 22, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589625 ↗
• InjuryMar 4, 2021Material Separation; Material Separation

  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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411070 ↗
• MalfunctionFeb 8, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CXI SUPPORT CATHETER HUB SEPARATED FROM THE CATHETER UPON INITIAL USE OF THE DEVICE AFTER PASSING THE WIRE GUIDE. THE PHYSICIAN REMOVED THE DEVICE AND ANOTHER CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252931 ↗