CXI G23864Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002238640), received between Oct 24, 2025 and Oct 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 24OCT2025. THE PROCEDURE INVOLVED MULTIPLE INTERVENTIONS INCLUDING INTRAVASCULAR LITHOTRIPSY, PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY, AND STENT PLACEMENT. THE PATIENT HAD MULTI-LEVEL AORTOILIAC OCCLUSIVE DISEASE OF THE RIGHT LOWER EXTREMITY, AND THE RIGHT SUPERFICIAL FEMORAL AND POSTERIOR TIBIAL ARTERIES WERE OCCLUDED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY TO TARGET THE RIGHT LOWER EXTREMITY, DOWN TO THE POSTERIOR TIBIAL ARTERY. THE CATHETER WAS ADVANCED THROUGH ANOTHER MANUFACTURER¿S 45-CENTIMETER SHEATH, AND MULTIPLE WIRES WERE USED DURING THE PROCEDURE. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF THE CATHETER. A POWER INJECTOR WAS NOT USED. THE DEVICE SEPARATED IN THE MIDDLE OF THE PROCEDURE. IT IS UNKNOWN WHAT WAS ATTACHED TO THE HUB AT THE TIME OF THE EVENT. THE CATHETER WAS MANUALLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH IN-LINE FLOW VIA PERONEAL ARTERY RUNOFF WITH MULTI-PHASIC PEDAL DOPPLER SIGNALS AFTER THE INTERVENTIONAL PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378661 ↗