CXI G23162Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002231627), received between Dec 15, 2016 and Nov 17, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, A CXI SUPPORT CATHETER SEPARATED. PER THE REPORTER, THE CXI WAS OVER AN UNKNOWN WIRE AND INSIDE OF ANOTHER MANUFACTURER'S 4-FRENCH CATHETER. DURING THE PROCEDURE, THE CXI "SNAPPED" IN TWO. WHEN THE USER REMOVED THE OTHER MANUFACTURER'S CATHETER, THE SEPARATED PORTION OF THE CXI WAS REPORTEDLY OUTSIDE OF THE SHEATH; THEREFORE, THE USER WAS ABLE TO MANUALLY REMOVE THE SEPARATED FRAGMENT. 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 23572452 ↗
• MalfunctionOct 11, 2023Material Perforation; Material Perforation

  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 17916212 ↗
• InjuryDec 28, 2022Break; 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 16060880 ↗
• InjuryAug 2, 2021Material Separation; Material Separation

  AS REPORTED, DURING AN ANGIOGRAM OF THE LOWER EXTREMITY WITH INTERVENTION, THE TIP OF A CXI SUPPORT CATHETER SEPARATED AS THE USER ATTEMPTED TO CROSS THE DISEASED POSTERIOR TIBIAL ARTERY. THE SEPARATED PORTION OF THE DEVICE WAS PUSHED DISTALLY INTO THE POSTERIOR TIBIAL ARTERY WITH AN UNKNOWN BALLOON AND REMAINS IN THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 12262639 ↗
• MalfunctionJan 21, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11207093 ↗
• MalfunctionMar 10, 2020Fracture; Fracture

  AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER BENT AND NEARLY SEPARATED UPON REMOVAL FROM THE PACKAGING. THE INITIAL REPORTER STATED THE DEVICE WAS STUCK INSIDE THE PLASTIC TUBING OF THE PACKAGING MATERIAL, REQUIRING ADDITIONAL FORCE TO REMOVE IT. ON RETURN INSPECTION OF THE DEVICE 06MAR2020, THE CATHETER TIP WAS KINKED WITH PARTIAL SEPARATION OF 3MM IN LENGTH. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 9810734 ↗
• MalfunctionOct 14, 2019Stretched; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED ON 14OCT2019. THE ANATOMY WAS CALCIFIED BUT NOT TORTUOUS. THERE WAS NO EVIDENCE OF STRETCHING PRIOR TO USE OR DURING THE PROCEDURE. EXCESSIVE RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE CATHETER, AND THE WIRE GUIDE FELT STUCK DURING REMOVAL BUT IT EVENTUALLY CAME OUT. THE HYDROPHILIC COATING WAS ACTIVATED BY FLUSHING THE DEVICE AND IMMERSING IT IN SALINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184933 ↗
• MalfunctionNov 2, 2017Material Perforation

  WHILE USING THE DEVICE, THE WIRE GUIDE PERFORATED THE CATHETER. THE PATIENT DID NOT REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. IN ADDITION, THE DEVICE DID NOT CAUSED OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6996441 ↗
• MalfunctionNov 1, 2017Split

  IT WAS REPORTED THAT THE TIP OF THE CATHETER SPLIT DOWN THE MIDDLE WHEN CROSSING THE TOTAL OCCLUSION. A NEW CXI DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994382 ↗
• MalfunctionJun 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING TREATMENT OF SUPERIOR FEMORAL ARTERY STENOSIS AND STENOSIS OF THE A. TIBIALIS ANTERIOR RIGHT SIDE USING A CXI SUPPORT CATHETER, WHEN WIRE WAS PULLED OUT FROM THE PATIENT, THE TIP BROKE OFF. 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 Known Impact Or Consequence To Patient

  MAUDE report 6605756 ↗
• MalfunctionApr 12, 2017Break; Break

  IT WAS REPORTED THAT DURING A BELOW THE KNEE (BTK) PROCEDURE USING A CXI SUPPORT CATHETER, WHILE INTRODUCING THE CATHETER OVER THE WIRE PRIOR TO PATIENT CONTACT, THE TIP OF THE CXI CATHETER BROKE. THE PATIENT WAS UNHARMED AS THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6486127 ↗
• InjuryDec 15, 2016Material Separation; Material Separation

  IT WAS REPORTED ACCESS IN THE PERONEAL ARTERY REVEALED TOTAL OCCLUSION. DURING ADVANCEMENT OF THE WIRE THROUGH THE LESION WHILE ADVANCING THE CXI CATHETER, AFTER ABOUT 10, 15 MINUTES OF TRYING TO CROSS THE LESION, THE PHYSICIAN PULLED BACK THE CATHETER AND THE TIP REMAINED INSIDE THE TOTAL OCCLUSION. A DIAMOND BACK DEVICE WAS USED TO OPEN THE LESION, THE TIP OF THE CATHETER REMAINED ON THE WIRE AS THEY SPUN AND THE TIP PROCEEDED TO MOVE MORE PROXIMAL ON THE WIRE. THE TIP WAS REMOVED FROM THE PATIENT AFTER ANGIPPLASTY WAS PERFORMED AND THE CATHETER WAS MANIPULATED TO REMOVE THE FRAGMENT. REPORTEDLY THE, ¿PATIENT IS FINE." 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: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6178812 ↗