CXI G56551Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002565517), received between May 12, 2017 and Apr 6, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Split, Cut or Torn

  AS REPORTED, PRIOR TO USE FOR A PROCEDURE INVOLVING ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY, A HOLE WAS NOTED IN A CXI SUPPORT CATHETER. REPORTEDLY, AS THE CATHETER WAS FLUSHED, FLUID WAS NOTED TO COME OUT OF A HOLE NEAR THE TIP OF THE CATHETER. THE DEVICE, WHICH WAS NOT USED, WAS DISCARDED. 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 24791523 ↗
• MalfunctionJun 3, 2025Break; Break

  AS REPORTED, DURING AN ANGIOGRAM, THE TIP OF A CXI SUPPORT CATHETER BROKE OFF. THE CATHETER WAS FLUSHED AND LOADED ONTO ANOTHER MANUFACTURER'S STIFF ANGLED WIRE GUIDE, WHICH WAS IN THE PATIENT, AND THE USER ATTEMPTED TO ADVANCE THE CATHETER. THE USER REPORTEDLY WET THE WIRE AND PULLED THE CATHETER BACK, AT WHICH POINT THE USER NOTED THAT THE TIP OF THE CATHETER BROKE OFF. THE CATHETER DID NOT MAKE CONTACT WITH THE PATIENT, AS IT WAS NOT ADVANCED FAR ENOUGH OVER THE WIRE TO ENTER THE BODY. A NEW COOK CATHETER WAS USED TO 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 22132993 ↗
• MalfunctionMay 29, 2025Break; Break

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. AS THE NURSE LOADED THE CATHETER ONTO ANOTHER MANUFACTURER¿S WIRE GUIDE ON THE STERILE TABLE, THE NURSE AND INTERVENTIONAL RADIOLOGIST NOTED THAT THE TIP OF THE CATHETER HAD SEPARATED ON THE WIRE. THE CATHETER DID NOT MAKE PATIENT CONTACT. A NEW CATHETER WAS USED TO 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 22105924 ↗
• MalfunctionFeb 26, 2025Break; Material Perforation; Break; 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 21468429 ↗
• MalfunctionApr 11, 2024Material Perforation; Material Perforation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED 0.018-INCH WIRE PERFORATED A CXI SUPPORT CATHETER. THE CATHETER WAS ADVANCED THROUGH AN UNKNOWN 4-FRENCH SHEATH. AN IPSILATERAL APPROACH WAS USED, AND THE ANATOMY WAS VERY TORTUOUS. AT THE BEGINNING OF THE PROCEDURE, BEFORE CROSSING THE STENOSED AREA, THE WIRE PERFORATED THE CATHETER ON ADVANCEMENT, EXITING THE TOP ("ANTERIOR TIP") OF THE CATHETER RATHER THAN THE EXIT HOLE AT THE CATHETER TIP. 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 19089640 ↗
• MalfunctionMar 7, 2024Break; Break

  AS ORIGINALLY REPORTED, DURING AN ANGIOPLASTY, THE HUB OF A CXI SUPPORT CATHETER SEPARATED. THE CATHETER WAS ADVANCED THROUGH AN UNSPECIFIED 6 FRENCH SHEATH FOR LEFT FEMORAL ACCESS TARGETING THE SUPERFICIAL FEMORAL ARTERY, IPSILATERALLY. THE ACCESS SITE WAS NOT SCARRED, HOWEVER, THE PATIENT'S ANATOMY WAS CALCIFIED. THE FITTING WAS WIPED DOWN WITH HEPARINIZED SALINE AND RESISTANCE WAS NOT FELT UPON ADVANCEMENT OF THE CATHETER. UPON REMOVAL, RESISTANCE WAS FELT AND THE CATHETER HUB "GAVE WAY". THE USER SUCCESSFULLY PULLED THE REMAINING CATHETER FROM THE PATIENT. FLUOROSCOPY WAS PERFORMED; HOWEVER, NO ADDITIONAL PROCEDURES WERE REQUIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, ON (B)(6) 2024, THE CATHETER SHAFT WAS SEPARATED BELOW THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858772 ↗
• InjuryMay 11, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 20JUN2023. IPSILATERAL ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, BUT THE ANATOMY WAS CALCIFIED. ANOTHER MANUFACTURER'S 0.035-INCH WIRE WAS USED DURING THE PROCEDURE, AS WELL AS AN UNSPECIFIED COOK CMW WIRE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE CATHETER. A POWER INJECTOR WAS NOT USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16911757 ↗
• MalfunctionSep 1, 2021Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12410254 ↗
• MalfunctionMay 18, 2021Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11840725 ↗
• InjuryApr 9, 2021Material Separation; Sharp Edges; Material Separation; Sharp Edges

  ADDITIONAL INFORMATION WAS RECEIVED 04MAY2021. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT AS ORIGINALLY REPORTED. THE DEVICE WAS REMOVED FROM THE PATIENT DURING THE PROCEDURE WITH NO HARM TO THE PATIENT. A POWER INJECTOR WAS NOT USED. UPON RECEIPT OF THE COMPLAINT DEVICE, THE CATHETER WAS NOT SEPARATED; HOWEVER, THE TIP WAS JAGGED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640444 ↗
• MalfunctionJan 15, 2020Material Separation; Material Separation

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9592919 ↗
• MalfunctionOct 31, 2017Detachment Of Device Component; Sticking

  PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT THE DISTAL END OF THE CATHETER WAS DETACHED. THE CXI WAS BEING LOADED ONTO A GUIDE WIRE, IT SEEMED TO STICK, AND SO IT WAS PULLED BACK A FEW CENTIMETERS TO WET/CLEAN THE WIRE AND IT WAS NOTICED THAT THE TIP HAD DETACHED. THE CXI HAD NOT BEEN ADVANCED THROUGH THE INTRODUCER AS IT WAS PRIOR TO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991776 ↗
• MalfunctionMay 12, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE CXI SUPPORT CATHETER BROKE OFF "WITHOUT ANY MASSIV(E) PUSH" BEFORE A PROCEDURE. THERE WAS REPORTEDLY NO PATIENT INVOLVED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6563216 ↗