CXI G23160Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002231603), received between Jun 21, 2019 and Aug 15, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Break

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING PREPARATION FOR A LEG ANGIOGRAM, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. THE CATHETER WAS FLUSHED NORMALLY, AND THE HUB WAS WIPED WITH SALINE. AS THE USER ATTEMPTED TO LOAD THE DEVICE ONTO ANOTHER MANUFACTURER¿S 0.014-INCH WIRE, THE VERY DISTAL TIP OF THE CATHETER SEPARATED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY 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 22814772 ↗
• MalfunctionMay 8, 2025Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. THE CATHETER MADE PATIENT CONTACT. PER THE REPORTER, A "BLACK PIECE" OF THE CATHETER CAME OFF THE TIP OF THE CATHETER. THE PIECE WAS REMOVED FROM THE UNSPECIFIED WIRE, FELL ON THE FLOOR, AND WAS UNABLE TO BE FOUND. ANOTHER CATHETER WAS USED WITHOUT ISSUE AND NO FURTHER INTERVENTIONS WERE REQUIRED. AT THIS TIME, NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21984242 ↗
• MalfunctionOct 17, 2023Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED IN A PATIENT. THE TIP WAS REMOVED WITH THE "LEADER" AS IT WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950121 ↗
• MalfunctionMar 22, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 25APR2023. THE ACCESS SITE WAS NOT SCARRED, BUT THE ANATOMY WAS TORTUOUS AND CALCIFIED. AN IPSILATERAL APPROACH WAS USED. THE EVENT OCCURRED IN THE MIDDLE OF THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE CATHETER, OR DURING ADVANCEMENT OF THE WIRE AND/OR CATHETER. A POWER INJECTOR WAS NOT USED. THE TIP OF THE CATHETER WAS REMOVED OVER THE WIRE, OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591469 ↗
• MalfunctionJul 13, 2022Break; Break

  AS REPORTED, A SMALL PIECE OF THE DISTAL TIP OF A CXI SUPPORT CATHETER SEPARATED PRIOR TO BEING USED IN THE PATIENT. THE USER HAD DIFFICULTY ADVANCING THE DEVICE ONTO THE WIRE WHEN THEY NOTICED THE SEPARATED TIP. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT DEVICE. 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 15008470 ↗
• MalfunctionAug 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  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 12365432 ↗
• MalfunctionJun 21, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE LEFT LOWER EXTREMITY FOR LIMB SALVAGE, INVOLVING A MALE PATIENT APPROXIMATELY 80 YEARS OF AGE, A CXI SUPPORT CATHETER SEPARATED AT THE HUB AND SUBSEQUENTLY SEPARATED INTO SEVERAL PIECES UPON REMOVAL. PEDAL ACCESS WAS OBTAINED BEHIND THE ANKLE BONE AND ANOTHER MANUFACTURER'S WIRE WAS USED. THE PATIENT'S ANATOMY WAS REPORTEDLY VERY CALCIFIED. WHILE BACKING THE CATHETER OFF THE WIRE BY PULLING ON THE HUB, THE HUB SEPARATED FROM THE SHEATH. RESISTANCE WAS REPORTED UPON REMOVAL OF THE DEVICE. THERE WAS NO BLOOD LOSS. THE FITTING WAS NOT ATTACHED TO ANOTHER DEVICE AT THE TIME OF SEPARATION. A "KELLY CLAMP" WAS USED TO PULL THE CATHETER BACK TO MAINTAIN ACCESS WITH THE OTHER MANUFACTURER'S WIRE. REPORTEDLY, WHILE FORCEFULLY PULLING THE CATHETER WITH THE CLAMP, THE CATHETER BROKE INTO SEVERAL PIECES. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. SOME OF THE PIECES WERE DISCARDED IN THE PROCEDURE ROOM. THIS EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). DURING THE SAME PROCEDURE, ANOTHER CXI SUPPORT CATHETER WAS USED IN THE PEDAL ACCESS SITE. ONCE THE DEVICE WAS REMOVED AND FLUSHED, IT WAS NOTED THAT THE DEVICE WAS LEAKING NEAR

  Patient problems: No Code Available

  MAUDE report 8724596 ↗