CXI G56553Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002565531), received between Feb 28, 2017 and Aug 19, 2025 — classified as 5 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Break; Break

  AS REPORTED, DURING A RIGHT LOWER EXTREMITY ANGIOGRAM, THE TIP OF A CXI SUPPORT CATHETER SEPARATED AS THE CATHETER WAS PUSHED DOWN THE SUPERFICIAL FEMORAL ARTERY (SFA). PER THE REPORTER, THE TIP BROKE OFF WITHIN THE PROXIMAL SFA, BEFORE REACHING THE LESION. THE SEPARATED FRAGMENT WAS STENTED AGAINST THE VESSEL WALL AND REMAINS IN THE PATIENT. PER THE REPORTER, THE PATIENT IS "DOING WELL". THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22841119 ↗
• MalfunctionMay 28, 2025Break; Break

  AS REPORTED, PRIOR TO USE FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT PERIPHERAL ARTERY OCCLUSIVE DISEASE, THE TIP OF A CXI SUPPORT CATHETER FRACTURED. THE TIP REPORTEDLY FRACTURED UPON ATTEMPTED INSERTION OF THE CATHETER INTO THE VALVE OF A COOK SHEATH, OVER ANOTHER MANUFACTURER'S WIRE GUIDE. PER THE REPORTER, THE CATHETER TIP DID NOT KINK OR COMPLETELY SEPARATE. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. A NEW CXI 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 22095531 ↗
• MalfunctionMay 12, 2025Material Perforation; Material Perforation

  AS REPORTED, DURING PREPARATION OF THE DEVICE FOR A LEFT COMMON FEMORAL ANGIOPLASTY, ANOTHER MANUFACTURER'S WIRE PERFORATED A CXI SUPPORT CATHETER. AFTER OPENING THE CATHETER, THE USER ATTEMPTED TO ADVANCE THE WIRE THROUGH THE CATHETER; HOWEVER, THE WIRE CAME OUT THE SIDE OF THE DEVICE. PER THE REPORTER, THE BLACK TIP WAS ALSO KINKED. THE WIRE WAS NOT ALTERED PRIOR TO ADVANCEMENT THROUGH THE CATHETER. A NEW CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER 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 22001933 ↗
• InjuryMar 14, 2025Break; Break

  AS REPORTED, DURING A UNILATERAL ANGIOGRAM AND PERIPHERAL INTERVENTION WITH TIBIAL ANGIOPLASTY AND PLACEMENT OF A POPLITEAL STENT, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. PER THE REPORTER, A "BLACK DOT" WAS NOTED IN THE POPLITEAL ARTERY. THE CXI CATHETER WAS REMOVED AND THE USER DISCOVERED THAT THE "BLACK DOT" WAS THE TIP OF THE CATHETER. UNDER FLUOROSCOPY, THE USER NOTED THAT THE SEPARATED TIP MIGRATED DISTALLY AND THEN WAS LOST. THE USER WAS NOT ABLE TO VISUALIZE THE FRAGMENT IN ANY DISTAL BRANCH OR COLLATERAL ARTERY DUE TO OVERLAPPING OF IMAGES AND ANATOMICAL STRUCTURES; THEREFORE, THE SEPARATED TIP COULD NOT BE RETRIEVED FROM THE PATIENT. PER THE REPORTER, THE CASE WAS NOT PARTICULARLY COMPLEX. REPORTEDLY, MAJOR CATHETER MANIPULATION WAS NOT REQUIRED TO CROSS LESIONS, WHICH WERE NOT HIGHLY CALCIFIED. 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 21607817 ↗
• MalfunctionMay 8, 2024Break; 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 19273738 ↗
• MalfunctionJan 15, 2024Break; Break

  AS REPORTED, DURING PREPARATION OF THE DEVICE FOR AN ANGIOGRAM OF THE LOWER EXTREMITY, THE BLACK DISTAL TIP OF A CXI SUPPORT CATHETER SEPARATED OUTSIDE OF THE PATIENT'S BODY. AN UNSPECIFIED 5-FRENCH, 11-CENTIMETER SHORT SHEATH WAS USED DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER'S WIRE; HOWEVER, THE COMPLAINT DEVICE WAS NOT INSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO COMPLICATIONS FOR 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18514971 ↗
• MalfunctionMay 12, 2023Break; Break

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEFT LEG, A CXI SUPPORT CATHETER SEPARATED AT THE HUB. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT ANTERIOR TIBIAL ARTERY. THE FITTING WAS WASHED/WIPED DOWN "PER THE IFU". THE ANATOMY WAS REPORTEDLY CALCIFIED, AND RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE, WHICH WAS UNABLE TO CROSS THE DIFFICULT LESION. TOWARDS THE "MIDDLE TO END" OF THE PROCEDURE, WHEN THE COMPLAINT DEVICE WAS INSIDE OF AN UNSPECIFIED 0.035-INCH CXI CATHETER, OVER A 0.018-INCH WIRE, THE CATHETER SEPARATED AT THE HUB. THE HUB WAS OUTSIDE OF THE PATIENT AT THE TIME OF SEPARATION, SO THE CATHETER WAS PULLED FROM THE PATIENT, MAINTAINING WIRE ACCESS. THE 0.035-INCH CXI WAS STILL IN THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE FITTING OF THE COMPLAINT DEVICE WAS REPORTEDLY NOT CONNECTED TO ANY OTHER DEVICE, AND A POWER INJECTOR WAS NOT USED. 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 OCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920211 ↗
• MalfunctionMay 12, 2023Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING LEFT PEDAL ACCESS TO TARGET THE ANTERIOR TIBIAL ARTERY, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. THE DEVICE WAS FLUSHED AND WIPED DOWN WITH HEPARINIZED SALINE. THE CATHETER WAS ADVANCED OVER ANOTHER MANUFACTURER'S 0.018-INCH WIRE GUIDE; HOWEVER, BEFORE THE CATHETER ENTERED THE SHEATH OR THE PATIENT, THE TIP KINKED AND SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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 16920061 ↗
• MalfunctionApr 12, 2023Material Separation; Material Separation

  AS REPORTED, PRIOR TO USE FOR A PROCEDURE INVOLVING A LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA AN ANTEGRADE APPROACH, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. THE DEVICE WAS FLUSHED IN THE SPIRAL HOLDER AS USUAL. NO DAMAGE WAS NOTED UPON REMOVAL OF THE CATHETER FROM THE HOLDER. AS THE CATHETER WAS ADVANCED OVER AN UNSPECIFIED WIRE GUIDE, 4.5-MILLIMETERS OF THE TIP SEPARATED FROM THE CATHETER. FORCE WAS NOT USED. THE CATHETER WAS NOT USED, AND THERE WAS NO HARM TO 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725592 ↗
• InjuryDec 8, 2022Break; Break

  AS REPORTED, DURING A PERIPHERAL RUNOFF PROCEDURE WITH INTERVENTION OF THE LEFT LEG, THE TIP OF AN UNSPECIFIED CXI SUPPORT CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET A TOTAL OCCLUSION LOCATED WITHIN THE ANTERIOR TIBIAL ARTERY. THE BIFURCATION WAS NOT TIGHT BUT THE ANATOMY WAS REPORTEDLY CALCIFIED, AND RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE DEVICE. ANOTHER MANUFACTURER'S 6 FRENCH SHEATH AND ANOTHER MANUFACTURER'S 0.018-INCH WIRE WERE USED DURING THE PROCEDURE. A POWER INJECTOR WAS NOT USED. THE DISTAL ANGLED TIP OF THE CATHETER REMAINS IN THE PATIENT'S LEFT TIBIAL ARTERY AND THERE ARE NO PLANS TO RETRIEVE THE FRAGMENT. 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 15945199 ↗
• InjuryOct 7, 2022Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED IN THE PATIENT. A SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15566331 ↗
• MalfunctionJul 28, 2022Break; Break

  AS REPORTED, TOWARDS THE "MIDDLE TO END" OF A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO TREAT A DISEASED TIBIAL VESSEL, THE GREEN HUB BROKE OFF A CXI SUPPORT CATHETER OUTSIDE THE PATIENT'S BODY. REPORTEDLY, THE 2.6 FRENCH CXI WAS BEING TELESCOPED THROUGH A 4 FRENCH, 90-CENTIMETER CXI. THE DEVICE WAS BEING ADVANCED/TORQUED OVER AN UNKNOWN MANUFACTURER'S .018 GLIDEWIRE WHEN THE SEPARATION OCCURRED. THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY, AND THE CATHETER WAS "MOSTLY" INSIDE THE ARTERY AT THE TIME OF THE SEPARATION. THE ANATOMY WAS CALCIFIED AND A POWER INJECTOR WAS NOT USED. THE SEPARATED PORTION OF THE DEVICE WAS RETRIEVED AND NOTHING REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. UPON RETURN AND EVALUATION OF THE DEVICE, THE SHAFT OF THE DEVICE SEPARATED OUTSIDE THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121782 ↗
• MalfunctionJul 13, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, FOREIGN SUBSTANCE (HAIR) WAS FOUND INSIDE OF THE PACKAGING OF AN UNUSED DEVICE. NO UNINTENDED 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 14999306 ↗
• MalfunctionApr 29, 2022Break; Break

  AS REPORTED, PRIOR TO USE DURING AN UNSPECIFIED PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER WAS FOUND TO BE BROKEN. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249799 ↗
• MalfunctionAug 19, 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 12341308 ↗
• MalfunctionAug 2, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED 13AUG2021. THE CATHETER DID NOT SEPARATE AS ORIGINALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263744 ↗
• MalfunctionJul 16, 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 12180154 ↗
• MalfunctionJul 15, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE TIP SEPARATED AS THE DEVICE WAS BEING LOADED OVER A WIRE GUIDE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT.

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

  MAUDE report 12178209 ↗
• MalfunctionJul 15, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 12176135 ↗
• MalfunctionMay 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768793 ↗
• MalfunctionFeb 15, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11327277 ↗
• MalfunctionOct 21, 2020Material Perforation; Material Perforation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, ANOTHER MANUFACTURER'S WIRE GUIDE PERFORATED A CXI SUPPORT CATHETER. THE HYDROPHILIC COATING REPORTEDLY CAME OFF OF THE OTHER MANUFACTURER'S WIRE GUIDE; HOWEVER, IT IS UNKNOWN IF THE COATING CAME OFF OF THE WIRE PRIOR TO OR AFTER THE WIRE PERFORATED THE CATHETER. 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 10710444 ↗
• InjuryAug 21, 2020Separation Problem; Separation Problem

  AS REPORTED, DURING AN ANGIOPLASTY AND STENTING PROCEDURE OF A STENOSED COMMON FEMORAL ARTERY IN WHICH A CXI SUPPORT CATHETER WAS USED, THE RADIOPAQUE MAKER POSSIBLY SEPARATED IN THE PATIENT. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED. A SIGNIFICANT AMOUNT OF PLAQUE WAS NOTED IN THE VESSEL. RESISTANCE WAS REPORTED UPON REMOVAL OF THE COMPLAINT DEVICE AS WELL AS ANOTHER MANUFACTURER'S WIRE GUIDE. AFTER THE DEVICE WAS REMOVED, THE PHYSICIAN FOUND ON X-RAY THAT A "TIP" WAS LEFT IN THE SUBINTIMAL PLANE. PER THE REPORTER, IT IS UNKNOWN IF THE RETAINED DEVICE FRAGMENT WAS A SEPARATED MARKER FROM THE COMPLAINT DEVICE OR THE TIP OF THE OTHER MANUFACTURER'S WIRE GUIDE. THE RETAINED DEVICE WAS NOT RETRIEVED, AND THERE ARE NO PLANS TO RETRIEVE THE FRAGMENT. BOTH THE COMPLAINT DEVICE AND OTHER MANUFACTURER'S WIRE WERE DISCARDED BY THE USER FACILITY. 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 10439401 ↗
• MalfunctionJul 24, 2020Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED ON 29JUL2020 STATING THAT THERE WAS NO PACKAGING DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321413 ↗
• MalfunctionOct 14, 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 9185612 ↗