CXI G18376Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002183766), received between Oct 31, 2017 and Nov 26, 2025 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Break; Break

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, A CXI SUPPORT CATHETER SEPARATED. THE HYDROPHILIC COATING WAS ACTIVATED, AND THE CATHETER WAS FLUSHED PER THE INSTRUCTIONS FOR USE. THE USER ATTEMPTED TO ADVANCE THE CATHETER OVER A 180-CENTIMETER COOK ROSEN WIRE; HOWEVER, THE CATHETER BECAME STUCK HALFWAY ON THE WIRE, PRIOR TO REACHING THE SHEATH. THE CATHETER DID NOT ENTER THE PATIENT'S BODY. THE PHYSICIAN THEN TRIED TO REMOVE THE CATHETER FROM THE WIRE, BUT THE CATHETER WAS STILL STUCK. THE PHYSICIAN THEN USED ADDITIONAL FORCE IN AN ATTEMPT TO REMOVE THE CATHETER FROM THE WIRE, AT WHICH POINT THE CATHETER SEPARATED INTO TWO PIECES, APPROXIMATELY TEN CENTIMETERS FROM THE DISTAL TIP. ADDITIONAL PIECES OF THE CATHETER REPORTEDLY BROKE OFF WHEN REMOVING THE REMAINING PORTION OF THE CATHETER FROM THE WIRE. AFTER THE SEPARATED CATHETER WAS REMOVED FROM THE WIRE, THE WIRE, WHICH WAS NOT REMOVED FROM THE PATIENT, WAS CLEANED AND CHECKED, AND ANOTHER CXI OF THE SAME TYPE WAS USED OVER THE SAME WIRE TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 23660070 ↗
• MalfunctionFeb 4, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM WITH BELOW-THE-KNEE INTERVENTION, DURING WHICH A CXI SUPPORT CATHETER WAS USED, THE TIP OF ANOTHER MANUFACTURER¿S 0.014-INCH, 300-CENTIMETER WIRE SEPARATED. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET A VESSEL BELOW THE KNEE. THE OTHER MANUFACTURER¿S WIRE WAS REPORTEDLY STICKING UPON BOTH ADVANCEMENT AND WITHDRAW OF THE WIRE THROUGH THE CATHETER. UPON REMOVAL OF THE WIRE FROM THE CATHETER, THE TIP OF THE WIRE SEPARATED. THE SEPARATED WIRE FRAGMENT WAS REMOVED WITH AN UNKNOWN SNARE CATHETER. THE CXI CATHETER WAS REPORTEDLY DAMAGED. REPORTEDLY, THE CUSTOMER CANNOT CONFIRM IF THE CXI CATHETER SEPARATED; HOWEVER, STATED THAT IF THE CATHETER HAD SEPARATED, IT WAS RETRIEVED. 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 21306779 ↗
• InjuryFeb 4, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM WITH BELOW-THE-KNEE INTERVENTION, DURING WHICH TWO CXI SUPPORT CATHETERS WERE USED, THE TIP OF ANOTHER MANUFACTURER¿S 0.014-INCH, 300-CENTIMETER WIRE GUIDE SEPARATED AND REMAINS IN THE PATIENT. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET A VESSEL BELOW THE KNEE. THE FIRST CATHETER AND WIRE WERE USED; HOWEVER, THE WIRE REPORTEDLY STUCK UPON BOTH ADVANCEMENT AND WITHDRAW OF THE WIRE THROUGH THE CATHETER. REPORTEDLY, UPON REMOVAL OF THE WIRE FROM THE CATHETER, ¿MATERIAL CAME OFF¿ OF THE WIRE. ANOTHER CXI AND ANOTHER 0.014-INCH, 300-CENTIMETER WIRE WERE THEN USED; HOWEVER, THE OTHER MANUFACTURER¿S WIRE ALSO STUCK UPON ADVANCEMENT AND WITHDRAW THROUGH THE CATHETER. THE WIRE AND CATHETER WERE REMOVED TOGETHER. THE CXI CATHETERS DID NOT SEPARATE. THE FRAGMENT OF THE OTHER MANUFACTURER¿S SEPARATED WIRE REMAINS IN THE ANTERIOR TIBIAL ARTERY, AS RETRIEVAL OF THE WIRE FRAGMENT WAS CONSIDERED ¿TOO RISKY¿. 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 21305294 ↗
• InjuryNov 27, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 19FEB2025. CONTRALATERAL ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL GROIN TARGETING THE LEFT POSTERIOR TIBIAL ARTERY. THE ANATOMY WAS MILDLY TORTUOUS. ANOTHER MANUFACTURER'S WIRE GUIDE AND A COOK WIRE GUIDE WERE USED THROUGH THE CATHETER DURING THE PROCEDURE. WHILE CROSSING THE POSTERIOR TIBIAL ARTERY THROUGH A 6FR SHEATH, APPROXIMATELY ONE MILLIMETER OF THE CXI'S TIP SEPARATED AND REMAINS IN THE POSTERIOR TIBIAL ARTERY WITH NO ADDITIONAL PROCEDURES BEING PERFORMED. A POWER INJECTOR WAS NOT USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20798755 ↗
• MalfunctionNov 17, 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 18160975 ↗
• MalfunctionApr 26, 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 16816904 ↗
• 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 16589586 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED, THAT PRIOR TO AN UNSPECIFIED PROCEDURE UPON OPENING THE SEALED PACKAGING OF A CXI SUPPORT CATHETER, THE TIP OF THE DEVICE FELL APART. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT UNSPECIFIED DEVICE. THERE WERE NO ADVERSE EFFECTS OR THE NEED FOR ADDITIONAL PROCEDURES REPORTED FOR THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373100 ↗
• InjuryApr 8, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 22APR2021. THE PATIENT'S ANATOMY WAS CALCIFIED. A POWER INJECTOR WAS NOT USED WITH THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11633275 ↗
• MalfunctionFeb 17, 2021Fracture; Material Separation; Stretched; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11337124 ↗
• MalfunctionFeb 18, 2020Material Separation; Material Separation

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

  Patient problems: No Patient Involvement

  MAUDE report 9720117 ↗
• MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595779 ↗
• MalfunctionJun 3, 2019Material Separation; Material Separation

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

  Patient problems: No Patient Involvement

  MAUDE report 8664254 ↗
• MalfunctionNov 5, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A RIGHT LEG UP-AND-OVER PROCEDURE ON A (B)(6) MALE USING A CXI SUPPORT CATHETER, A PORTION FROM THE TIP OF THE DEVICE SEPARATED. ACCESS WAS VIA THE LEFT COMMON FEMORAL ARTERY, AND THE PATIENT'S ANATOMY WAS SAID NOT TO HAVE BEEN TORTUOUS, BUT MODERATELY CALCIFIED. THE COMPLAINT DEVICE WAS ABLE TO BE ADVANCED AND THEN REMOVED TO INSERT A BALLOON DEVICE. IT WAS REPORTED THAT THERE WAS NO RESISTANCE FELT DURING THE INSERTION OR THE REMOVAL OF THE DEVICE. WHILE THE DEVICE WAS ON THE BACK TABLE AND BEFORE IT WAS GRABBED TO BE USED AGAIN IN THE PROCEDURE, IT WAS THEN OBSERVED THAT THE BLACK DISTAL TIP HAD SEPARATED ON THE BACK TABLE. NOTHING HAD DETACHED WHILE IT WAS IN THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PHOTO'S OF THE DEVICE WERE REQUESTED; HOWEVER, THEY ARE NOT AVAILABLE AT THIS TIME. 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 Consequences Or Impact To Patient

  MAUDE report 8037119 ↗
• MalfunctionNov 7, 2017Sticking; Failure to Advance

  THE CATHETER WAS FLUSHED WITHOUT ISSUE AND ADVANCED THROUGH THE SHEATH AND DOWN INTO THE PATIENTS TIBIALS TO THE TARGET AREA. THE GUIDEWIRE WAS THEN ADVANCED DOWN THE CATHTER BUT AS IT APPROACHED THE TIP, THE WIRE COULD NO LONGER BE ADVANCED. THIS WIRE WAS THEN REPLACED WITH ANOTHER WIRE, BUT THE SAME ISSUE OCCURRED. THE WIRE AND CATHETER WERE THEN REMOVED AND IT WAS OBSERVED THAT A PIECE OF PLASTIC WAS STUCK ON THE TIP OF THE CATHETER. THE WIRE AND CATHETER WERE PLACED ASIDE, THE CASE WAS COMPLETED WITH ANOTHER CATHETER. NO PIECES OF THE COMPLAINT DEVICE REMAINED IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7007113 ↗
• MalfunctionOct 31, 2017Break

  IT WAS REPORTED THAT THE TIP OF THE CXI CATHETER CAME/BROKE OFF WHILE ADVANCING A WIRE THROUGH THE CATHETER PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6991863 ↗