CXI G52544Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002525443), received between Sep 18, 2017 and May 22, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Break; Break

  AS REPORTED, UPON OPENING THE DEVICE PACKAGE PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE USER NOTED THAT THE TIP OF A CXI SUPPORT CATHETER WAS BENT AND ¿IT LOOKED LIKE THE COILED HAD COME LOOSE.¿ 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 22069756 ↗
• MalfunctionJun 14, 2024Break; Break

  AS REPORTED, DURING AN UNSPECIFIED VASCULAR PROCEDURE, A CXI SUPPORT CATHETER SEPARATED UPON REMOVAL OF THE DEVICE. PER THE REPORTER, THE CATHETER BROKE IN MULTIPLE LOCATIONS ALONG THE SHAFT AND AT THE HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICE. ALL CATHETER FRAGMENTS WERE REMOVED MANUALLY OVER THE UNKNOWN WIRE GUIDE. 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 19537492 ↗
• MalfunctionOct 26, 2021Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697556 ↗
• MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 9595751 ↗
• InjuryJul 11, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED, DURING A PROCEDURE TO TREAT THE CHRONIC TOTAL OCCLUSION (CTO) OF THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA), THE PHYSICIAN COULD NOT ADVANCE THE CXI SUPPORT CATHETER THROUGH THE TARGET LESION. THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AT THE DISCRETION OF THE PHYSICIAN BECAUSE IT WAS "FELT SOMETHING WAS WRONG". SUBSEQUENTLY, ANOTHER MANUFACTURER'S MICRO CATHETER WAS SELECTED TO CONTINUE THE PROCEDURE; HOWEVER, BECAUSE A WIRE GUIDE COULD NOT ADVANCE THROUGH THE TRUE LUMEN, THE PROCEDURE WAS STOPPED WITH NO FURTHER TREATMENT. THE PROCEDURE WAS RESCHEDULED FOR THE END OF (B)(6) 2018 TO BE COMPLETED AT ANOTHER FACILITY BY A DIFFERENT PHYSICIAN. ACCORDING TO THE INITIAL REPORTER, THERE HAVE BEEN NO PATIENT ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7677213 ↗
• MalfunctionNov 22, 2017Delamination; Delamination

  IT WAS REPORTED THAT DURING THE PERIPHERAL VASCULAR PROCEDURE, WHITE PIECES OF THE CXI SUPPORT CATHETER COATING WERE COMING OFF. THE DELAMINATED MATERIAL DID NOT ENTER THE PATIENT'S ANATOMY. 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 7053988 ↗
• MalfunctionNov 17, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING INCOMING INSPECTION OF THE DEVICE AT THE DISTRIBUTER, IT WAS OBSERVED THAT A PIECE OF AN UNIDENTIFIED PARTICLE WAS INSIDE THE PRIMARY PACKAGE. THIS DEVICE WAS NOT USED AT A FACILITY. NO PATIENT CONTACT WAS MADE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7042068 ↗
• MalfunctionOct 31, 2017Kinked; Stretched

  DURING ATTEMPT TO EXCHANGE A WIRE, THE WIRE WOULD KINK WHILE TRYING TO PASS THROUGH THE CATHETER. THE DEVICE WAS ALSO NOTED TO HAVE STRETCHED. A SECOND CATHETER WAS USED AND THE SAME DIFFICULTY OCCURRED. THE PROCEDURE WAS ENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AND 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 6990649 ↗
• MalfunctionSep 18, 2017Break; Material Separation; Break; Material Separation

  A CXI SUPPORT CATHETER WAS USED DURING MULTIPLE PROCEDURES. PER A VOLUNTARY MEDWATCH (# (B)(4)), IT WAS REPORTED THAT UPON REMOVAL OF THE CATHETER OVER AN AMPLATZ WIRE, THE LUER-LOCK HUB BROKE OFF OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872010 ↗