CXI G18373Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002183735), received between Nov 11, 2016 and Aug 11, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210548 ↗
• MalfunctionNov 14, 2025Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE DISTAL TIP OF A CXI SUPPORT CATHETER "BROKE IN TWO" OUTSIDE OF THE PATIENT DURING REMOVAL OF THE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559776 ↗
• MalfunctionOct 22, 2025Break; 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 23357706 ↗
• MalfunctionAug 6, 2025Break; Break

  AS REPORTED, DURING A PERIPHERAL LEG CASE, A CXI SUPPORT CATHETER SEPARATED INTO MULTIPLE PIECES "CLOSE TO THE TIP" WHILE INSIDE AN UNSPECIFIED SHEATH. THE SHEATH WAS REMOVED WITH THE BROKEN CATHETER INSIDE. NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE SEPARATED CATHETER FROM THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730353 ↗
• MalfunctionJul 15, 2025Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER BROKE OFF. THIS ISSUE WAS FOUND PRIOR TO PATIENT CONTACT WHEN THE PACKAGE WAS OPENED. 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 22512672 ↗
• MalfunctionJun 27, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 02SEP2025. ACCESS WAS OBTAINED IN THE GROIN FOR THE ¿PERIPHERAL CASE¿ INVOLVING A CHALLENGING OCCLUSION WITHIN THE LEG. THE CATHETER WAS ADVANCED THROUGH AN UNKNOWN SHEATH. A POWER INJECTOR WAS NOT USED WITH THE COMPLAINT DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS ¿OKAY¿.

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

  MAUDE report 22349714 ↗
• MalfunctionJun 13, 2025Break; Break

  AS REPORTED, PRIOR TO USE DURING AN ANGIOGRAM OF THE LEG, THE DISTAL TIP OF A CXI SUPPORT CATHETER BROKE/PARTIALLY SEPARATED AT A NINETY-DEGREE ANGLE AND WAS ¿BARELY HANGING ON¿. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER MANUFACTURER¿S CATHETER 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 22205779 ↗
• MalfunctionApr 18, 2024Break; 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 19130199 ↗
• MalfunctionJan 3, 2024Break; Break

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. AFTER THE CATHETER AND AN UNSPECIFIED WIRE WERE FLUSHED, THE WIRE WAS INSERTED INTO CATHETER AND "HOOKED". WHEN THE WIRE WAS WITHDRAWN, THE TIP OF THE CXI CATHETER BROKE OFF. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 18440390 ↗
• MalfunctionJun 29, 2022Break; Break

  AS REPORTED, DURING A CASE INVOLVING A "RIGHT LL'S" CRITICAL ISCHEMIA WITH ANGIOPLASTY AND STENTING, THE DISTAL TIP OF A 2.3FR 150CM CXI SUPPORT CATHETER WAS BUCKLED WHEN IT WAS REMOVED FROM THE PACKAGING. IT FAILED TO LOAD INTO THE 0.014 HYDROST GUIDEWIRE. PHOTOS OF THE DEVICE APPEARED TO SHOW THAT THE DISTAL TIP WAS ALSO PARTIALLY SEPARATED. NO 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 14857695 ↗
• MalfunctionMar 31, 2022Break; Complete Blockage; Break; Complete Blockage

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER SEPARATED PRIOR TO USE. THE USER ATTEMPTED TO FLUSH THE DEVICE, HOWEVER, THE CATHETER WOULD NOT FLUSH. THE USER ADVANCED A WIRE TO CLEAR THE DEVICE, AND A RESIDUE REPORTEDLY CAME OUT OF THE CATHETER, WHICH THEN SEPARATED. ANOTHER CXI OF THE SAME TYPE WAS USED TO FINISH THE PROCEDURE, WITH NO FURTHER COMPLICATIONS. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13968978 ↗
• MalfunctionJan 28, 2022Break; Break

  AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE THE TIP OF A CXI SUPPORT CATHETER BROKE OFF AS THE DEVICE WAS BEING PREPARED FOR THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

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

  MAUDE report 13385815 ↗
• MalfunctionJul 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180129 ↗
• InjuryNov 5, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 05NOV2019. AS REPORTED, THE EVENT OCCURRED AT THE BEGINNING OF A LEG ANGIOGRAM WITH INTERVENTION. THE ANATOMY WAS CALCIFIED. NO RESISTANCE WAS REPORTED. A POWER INJECTOR WAS NOT USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9279226 ↗
• InjuryApr 24, 2019Material Separation; Material Separation

  AS REPORTED, DURING AN ANGIOGRAM WITH INTERVENTION OF THE LEFT LEG, A CXI SUPPORT CATHETER SEPARATED IN THE ANTERIOR TIBIAL ARTERY. THE (B)(6) MALE PATIENT, WEIGHING (B)(6) POUNDS, REPORTEDLY HAD A HISTORY SIGNIFICANT FOR ULCERS ON THE TOES AND NO BLOOD FLOW BELOW THE KNEE. ACCESS WAS OBTAINED IN THE GROIN AND AN UNKNOWN 6 FRENCH SHEATH AND UNKNOWN WIRE GUIDE WERE USED DURING THE PROCEDURE. A POWER INJECTOR WAS NOT USED. DURING THE PROCEDURE, RESISTANCE WAS REPORTED, AND THE PHYSICIAN ¿STRUGGLED¿ TO ADVANCE THE CATHETER OR APPLY TORQUE TO THE DEVICE. WHILE THE PHYSICIAN WAS ATTEMPTING TO CROSS A ¿VERY CALCIFIED¿ LESION, A 20-CENTIMETER SEGMENT OF THE DEVICE SEPARATED FROM THE TIP. THE PHYSICIAN WAS ABLE TO REMOVE THE SEPARATED PORTION OF THE DEVICE THROUGH AN UNKNOWN 5 FRENCH CATHETER VIA A SMALL INCISION IN THE SKIN ABOVE THE ACCESS SITE. THE INTENDED PROCEDURE WAS ABORTED, AND THE PATIENT WILL RETURN FOR ANOTHER INTERVENTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8545901 ↗
• MalfunctionJul 25, 2018Material Separation; Material Separation

  IT WAS REPORTED, A CXI SUPPORT CATHETER SEPARATED INTO TWO PIECES "ABOUT 10 INCHES (DISTAL) FROM THE HUB", DURING A PERIPHERAL INTERVENTION PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE SEPARATED UPON RETRIEVAL THROUGH THE TERUMO SHEATH ON A "HYDRO ST. WIRE." BOTH PIECES OF THE CATHETER WERE REMOVED FROM THE PATIENT. THERE WERE NO COMPLICATIONS, AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. 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 Known Impact Or Consequence To Patient

  MAUDE report 7718143 ↗
• InjuryNov 17, 2017Kinked; Material Separation; Kinked; Material Separation

  AN (B)(6) YEAR OLD MALE PATIENT WITH SEVERE PAD WAS UNDERGOING A PERIPHERAL INTERVENTION PROCEDURE WITH ACCESS IN RIGHT DISTAL ANTERIOR TIBIAL. IT WAS REPORTED THAT DURING THIS PROCEDURE, TWO CXI SUPPORT CATHETERS MALFUNCTIONED. THE INITIAL REPORTER STATED THAT THIS WAS THE SECOND PROCEDURE OVER THE COURSE OF DAYS THAT A PHYSICIAN TRIED TO RESOLVE THIS DIFFICULT LESION. ANOTHER MANUFACTURER'S SHEATH WAS PLACED ALONG WITH THE FIRST CXI CATHETER. THE PHYSICIAN REPORTED DIFFICULTY WHEN TRYING TO ADVANCE TWO WIRE GUIDES FROM ANOTHER MANUFACTURER THROUGH THE CXI. ADVANCEMENT OF A THIRD UNKNOWN WIRE WASN'T POSSIBLE AND THE PHYSICIAN HAD THOUGHT A KINK AT THE BASE OF THE HUB OF THE CXI HAD RESULTED. THE PHYSICIAN THEN CUT THE HUB FROM THE CXI IN ORDER TO ADVANCE A WIRE THROUGH IT TO PREVENT LOSS OF POSITIONING BEFORE REMOVING THE COMPLAINT DEVICE. A SECOND CXI WAS THEN PLACED OVER THE UNSPECIFIED WIRE GUIDE. OVER THE COURSE OF 45 MINUTES, THE PHYSICIAN TRIED ADVANCING MANY WIRE GUIDES. UPON CROSSING THE LESION WITH A WIRE, THE CXI WAS ADVANCED. THE PHYSICIAN NOTICED THAT TIP APPEARED TO NOT BEING ADVANCING ON IMAGING EVEN THOUGH THE HUB OF THE CXI CATHETER WAS ADVANCING FURTHER INTO THE S

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 7042543 ↗
• MalfunctionOct 31, 2017Split

  THE FOLLOWING INFORMATION WAS REPORTED: DURING AN ABOVE THE KNEE ANGIOPLASTY, THE PHYSICIAN WAS INSERTING THE CXI SUPPORT CATHETER OVER ANOTHER MANUFACTURER'S WIRE. THE WIRE WAS PROLAPSED OVER AND THE CATHETER WAS ADVANCED WHEN THE WIRE SHEARED/SPLIT THE DISTAL TIP OF THE CATHETER UPWARD. THE CATHETER WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991592 ↗
• MalfunctionOct 31, 2017Break; Difficult to Remove; Failure to Advance

  THE FOLLOWING INFORMATION WAS REPORTED: AN ARTERIOGRAM ON THE RIGHT LEG WITH LEFT GROIN ACCESS WAS BEING PERFORMED. THE PHYSICIAN WAS PLACING THE VERTEBRAL CATHETER (VERT) THROUGH A 6F SHEATH THAT WAS PLACED UP AND OVER THE AORTIC BIFURCATION AND GOT INTO POSITION. THE CXI SUPPORT CATHETER WAS PLACED THROUGH THE VERTEBRAL CATHETER WHEN RESISTANCE WAS MET. IT WAS THOUGHT THAT THE RESISTANCE WAS AT THE TIP WHERE THE VERT TAKES AN ANGLE. THE PHYSICIAN HAD TO PULL THE VERT BACK OVER THE BIFURCATION AND PUT THE CXI ALL THE WAY DOWN, THEN ADVANCE THE VERT OVER THE CXI (AN EXTRA STEP BECAUSE THE CXI WOULDN'T ADVANCE THROUGH THE VERT). THE PHYSICIAN THEN ATTEMPTED TO TAKE THE WIRE (CTO WIRE) OUT OF THE CXI AND IT WOULD NOT REMOVE FROM THE CXI. HE TRIED TO BACK THE CXI OFF THE WIRE TO TAKE IT OUT FEELING THE CXI WAS THE ISSUE AND IT WOULDN'T COME OUT. HE PULLED SO MUCH THAT THE CXI BROKE. THE CXI AND WIRE HAD TO BE REMOVED TOGETHER. THIS CAUSED THE PHYSICIAN TO LOSE HIS WIRE ACCESS DOWN THE LEG AND HE OPTED TO STICK FROM THE FOOT TO TREAT THE PATIENT. IT WAS FURTHER NOTED THAT THE CATHETER WAS SEVERED IN TWO PLACES (3 MM FROM THE HUB AND 18.5 CM FROM THE FIRST SEPARATION). THE PROCEDURE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991450 ↗
• MalfunctionOct 31, 2017Sticking; Stretched

  IT WAS REPORTED THAT THE WIRE GUIDE BECAME STUCK IN CATHETER AND THE DEVICES WERE REMOVED TOGETHER. IT WAS FURTHER NOTED THAT THE CATHETER WAS STRETCHED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991392 ↗
• MalfunctionOct 30, 2017Difficult to Advance

  THE CUSTOMER REPORTED THAT THEY COULD NOT INSERT THE WIRE THROUGH THE CATHETER HUB INITIALLY, BUT EVENTUALLY THEY GOT THE WIRE THROUGH. AFTER ACCESS TO THE LESION WAS GAINED, THE PHYSICIAN TRIED TO SUCTION BACK WITH A SYRINGE BUT NOTHING WOULD COME BACK. HE THEN TRIED TO INSERT THE WIRE AGAIN, BUT NEITHER END OF THE WIRE WOULD GO THROUGH. HE SAID IT FELT LIKE SOMETHING WAS BLOCKING PASSAGE THROUGH THE CATHETER. THE CUSTOMER REPORTED THAT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES, AND NO BREAKAGE OR SEPARATION OF THE DEVICE COMPONENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6987861 ↗
• MalfunctionNov 11, 2016Break; Break

  IT WAS REPORTED A .014 CXI CATHETER WAS ADVANCED THOUGH THE .014 WIRE INTO THE PERONEAL ARTERY AND BROKE OFF. REPORTEDLY ALL FRAGMENTS WERE REMOVED AND THE PROCEDURE CONTINUED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS 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 Known Impact Or Consequence To Patient

  MAUDE report 6096114 ↗