CXI G23859Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002238596), received between Oct 31, 2017 and Oct 31, 2023 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2023Break; Break

  AS REPORTED, DURING AN ENDOVASCULAR INTERVENTION AND ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA), TWO CXI SUPPORT CATHETERS SEPARATED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY TO TARGET THE LEFT SFA. THE ANATOMY WAS BOTH TORTUOUS AND CALCIFIED, AND THE BIFURCATION WAS ALSO REPORTEDLY CALCIFIED. AN UNSPECIFIED BALLOON, WIRE, AND LASER ATHERECTOMY DEVICE WERE USED DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER'S SHEATH. A POWER INJECTOR WAS NOT USED. RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF BOTH CATHETERS. AS THE WIRE WAS PINNED DOWN AND THE USER ATTEMPTED TO PULL THE CATHETERS FROM THE PATIENT, THE CATHETERS "SNAPPED IN TWO". THE CATHETERS WERE BOTH MANUALLY REMOVED, OVER THE WIRE GUIDE AND THROUGH THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICES. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039892 ↗
• InjuryMay 11, 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 16915083 ↗
• MalfunctionOct 31, 2017Melted

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING/TESTING THE 2.3" CXI SUPPORT CATHETER WITH A 0.14" WIRE GUIDE DURING A BTK (BELOW THE KNEE) PROCEDURE, AND THE TIP OF THE CATHETER MELTED TOGETHER WITH THE WIRE. IT WAS FURTHER NOTED THAT THE COATING ON ANOTHER MANUFACTURER'S WIRE GUIDE WAS STRIPPED DURING THE PROCEDURE AND THE DEVICE WAS SPLIT AT THE TIP. NOTHING HAPPENED TO THE PATIENT AND NOTHING WAS LEFT IN THE PATIENT'S ARTERY. NO FURTHER TREATMENT TO THE PATIENT WAS PERFORMED AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990383 ↗