CXI G50003Recalls & reported problems
Cook Incorporated · CXI Support Catheter · Class 2
Quick summary
This Cook Medical CXI support catheter is a thin, continuously flushed tube used to guide wires and deliver treatment during endovascular procedures. The 29 reports mostly describe the catheter breaking apart, perforating or splitting, or being punctured by other wires, and in some cases being hard to remove. Two reports involve injuries and no deaths were reported. There are no recalls naming this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002500037), received between Aug 23, 2016 and Feb 22, 2023 — classified as 2 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Material Separation” (9 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
Device problems
- Material Separation9
- Material Perforation4
- Break2
- Detachment of Device or Device Component2
- Difficult to Remove2
- Fracture2
- Material Puncture/Hole2
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient13
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions6
- No Patient Involvement3
- No Code Available1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2023Material Perforation; Material Perforation
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY, A CXI SUPPORT CATHETER WAS PERFORATED BY ANOTHER MANUFACTURER'S WIRE GUIDE. UPON OPENING THE DEVICE, A SUBTLE BEND WAS NOTED AT THE TIP OF THE CATHETER; HOWEVER, RETROGRADE ACCESS WAS OBTAINED IN THE ANTERIOR TIBIAL ARTERY AND THE CATHETER WAS PASSED OVER THE OTHER MANUFACTURER'S 0.014-INCH WIRE GUIDE. REPORTEDLY, THE WIRE PASSED EASILY THROUGH THE CATHETER, BUT PERFORATED THE CATHETER THROUGH A "TINY HOLE" AND WENT PAST THE CATHETER TIP. THE DEVICE WAS REPORTEDLY DIFFICULT TO RETRIEVE SAFELY AND THEREFORE THE DEVICE WAS RETRIEVED THROUGH ANOTHER PUNCTURE SITE. IT IS UNKNOWN WHAT DEVICES WERE USED TO RETRIEVE THE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16419109 ↗MalfunctionJul 6, 2022Break; Break
AS REPORTED, DURING ANGIOPLASTY, A A CXI SUPPORT CATHETER SEPARATED. THE DEVICE WAS FLUSHED FROM THE HUB, REMOVED FROM THE HOLDER, THEN ADVANCED OVER ANOTHER MANUFACTURER'S WIRE GUIDE AND THROUGH ANOTHER MANUFACTURER'S SHEATH. UPON REACHING THE DISTAL SUPERFICIAL FEMORAL ARTERY, THE LESION WAS TOTALLY OCCLUDED. THE USER FELT RESISTANCE TO CONTINUED ADVANCEMENT AND REMOVED THE DEVICE, NOTICING THAT THE HUB HAD DETACHED. A NEW DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. UPON INSPECTION OF THE RETURNED DEVICE, THE SHAFT OF THE DEVICE WAS SEPARATED WITHIN THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14940056 ↗MalfunctionAug 25, 2021Material Perforation; Material Perforation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367100 ↗MalfunctionJul 15, 2021Material Separation; Material Separation
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS EMDR WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172807 ↗MalfunctionApr 1, 2021Unsealed Device Packaging; Unsealed Device Packaging
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 11604679 ↗MalfunctionDec 31, 2020Material Perforation; Material Perforation
AS REPORTED, DURING AN ENDOVASCULAR TREATMENT PROCEDURE, ANOTHER MANUFACTURER'S 0.014-INCH WIRE GUIDE PERFORATED A CXI SUPPORT CATHETER. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND AN IPSILATERAL APPROACH WAS USED TO TARGET A CHRONIC TOTAL OCCLUSION WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OTHER MANUFACTURER'S WIRE GUIDE WAS INSERTED INTO THE COMPLAINT DEVICE AND DURING USE, THE WIRE PERFORATED THE MIDDLE OF THE CATHETER, REPORTEDLY COMING OUT OF THE DEVICE. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. ALTHOUGH THE LESION IN THE SFA WAS TOTALLY OCCLUDED, CALCIFICATION WAS NOT REPORTED. THE ANATOMY WAS NOT TORTUOUS. RESISTANCE WAS NOT REPORTED AS THE WIRE GUIDE WAS ADVANCED INTO THE CATHETER. 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; No Consequences Or Impact To Patient
MAUDE report 11100565 ↗MalfunctionSep 22, 2020Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10570164 ↗MalfunctionJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10250064 ↗MalfunctionJan 29, 2020Material 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 Consequences Or Impact To Patient
MAUDE report 9642576 ↗MalfunctionOct 10, 2019Sharp Edges; Sharp Edges
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 9176777 ↗MalfunctionAug 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS CONFIRMED THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED ON 07OCT2019. AN UNKNOWN, NON-COOK WIRE GUIDE WAS RETURNED BY MISTAKE PER THE USER FACILITY. NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8901293 ↗MalfunctionJul 16, 2019Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 17JUL2019 STATING THAT ANOTHER MANUFACTURER'S NON-HYDROPHILIC WIRE GUIDE WAS USED DURING THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8796692 ↗MalfunctionJan 14, 2019Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8245845 ↗MalfunctionAug 31, 2018Material Integrity Problem; Material Integrity Problem
IT WAS ORIGINALLY REPORTED, THE CXI SUPPORT CATHETER HAD A DAMAGED TIP DURING AN ENDOSCOPIC THIRD VENTRICULOSTOMY PROCEDURE. 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. UPON RETURN AND EXAMINATION OF THE COMPLAINT DEVICE, HOWEVER, IT WAS NOTED THAT THERE WAS SLIGHT SKIVE DAMAGE ALONG THE EXTERIOR PORTION OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7838044 ↗MalfunctionJul 10, 2018Material Separation; Material Separation
IT WAS REPORTED, IN AN ENDOVASCULAR REVASCULARIZATION OF A CHRONIC OCCLUSION IN THE LEFT ANTERIOR TIBIAL ARTERY, A CXI SUPPORT CATHETER SEPARATED WHILE THE PHYSICIAN WAS USING THE "SAFARI" TECHNIQUE. THE SEPARATED LENGTH WAS APPROXIMATELY 3-4 INCHES LONG, AND WAS SUCCESSFULLY REMOVED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 7673549 ↗MalfunctionJun 22, 2018Break
CXI SUPPORT CATH REF G5003. WHEN TRYING TO DILATE A VESSEL IN THE LEG THE CATHETER BROKE INSIDE ABOUT A 3-4 INCH PIECE. IT WAS ABLE TO BE RETRIEVED. IT IS A COOK MEDICAL PRODUCT. THE PACKAGE AND THE DEVICE WERE SAVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7629004 ↗MalfunctionMay 29, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT DURING DILATION OF A CHRONIC TOTAL OBSTRUCTION (CTO) OF A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), A CXI SUPPORT CATHETER WAS FOUND TO BE BROKEN AND SEPARATED UPON REMOVAL FROM THE PATIENT (REFER TO MEDWATCH 1820334-2018-01530). A SECOND CXI SUPPORT CATHETER WAS USED AND IT, TOO, WAS FOUND TO BE BROKEN AND SEPARATED UPON REMOVAL FROM THE PATIENT (REFER TO THIS REPORT). DURING THE PROCEDURE, ANOTHER MANUFACTURER'S 0.018 INCH WIRE GUIDE WAS ADVANCED CONTRALATERALLY FROM THE RIGHT FEMORAL ARTERY (FA) PAST THE CTO LESION (10CM IN LENGTH) IN THE LEFT SFA. THE CXI SUPPORT CATHETER (REFER TO MEDWATCH 1820334-2018-01530) WAS ADVANCED OVER THE WIRE GUIDE PAST THE TARGET LESION. UPON REMOVAL OF THE COMPLAINT DEVICE, THE PHYSICIAN REPORTEDLY FELT RESISTANCE AND APPLIED TORQUE PULLING ON IT FORCEFULLY. THE CXI SUPPORT CATHETER WAS SUCCESSFULLY REMOVED; HOWEVER, IT WAS OBSERVED TO BE BROKEN AND SEPARATED AT THAT TIME. NO SECTION OF THIS COMPLAINT DEVICE REMAINED IN THE PATIENT'S ANATOMY. A SECOND CXI SUPPORT CATHETER (REFER TO THIS REPORT) WAS ADVANCED OVER THE SAME WIRE GUIDE AND AGAIN, RESISTANCE WAS FELT UPON REMOVAL. THE PHYSICIAN APPLIED TORQUE AND PULLED
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7550265 ↗MalfunctionMar 12, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CXI SUPPORT CATHETER HUB FELL OFF DURING CONTRALATERAL ADVANCEMENT OF THE CATHETER FROM THE LEFT FEMORAL ARTERY TO THE SEVERELY STENOSED LESION. ANOTHER CXI SUPPORT CATHETER OF THE SAME LOT WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7330927 ↗MalfunctionDec 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WHITE FOREIGN MATTER, SUCH AS PAPER, WAS FOUND ON THE TIP OF THE CXI SUPPORT CATHETER WHEN THE DEVICE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO PATIENT CONTACT WAS MADE WITH THE COMPLAINT DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7155262 ↗MalfunctionNov 2, 2017Fracture
DURING THE PAOD (PERIPHERAL ARTERIAL VASCULAR OCCLUSIVE DISEASE) PROCEDURE, THE SUPPORTING CATHETER WAS FRACTURED FROM THE PROXIMAL WHEN INSERTED INTO THE PATIENT. THE PHYSICIAN USED A NEW DEVICE FOR THE PROCEDURE. THERE WERE NO REPORTED SECTIONS OF THE DEVICE LEFT INSIDE THE PATIENT¿S BODY OR ADDITIONAL PROCEDURES AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6996333 ↗MalfunctionNov 1, 2017Device Dislodged or Dislocated
IT WAS REPORTED THAT THE CATHETER HUB SEPARATED FROM THE CATHETER SHAFT DURING A LOWER EXTREMITY ANGIOGRAPHY PROCEDURE. THE PHYSICIAN STOPPED THE PROCEDURE, REMOVED THE DEVICE, AND PLANNED TO RESCHEDULE THE PROCEDURE. THERE WERE NO REPORTS OF ANY SECTIONS OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6994289 ↗MalfunctionNov 1, 2017Detachment Of Device Component
DURING PREPARATION OF THE CATHETER THE HUB DETACHED. THE DEVICE WAS NOT USED AND THERE WAS NO HARM TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6992660 ↗MalfunctionOct 31, 2017Difficult to Remove; Torn Material
THE CXI CATHETER WAS INSIDE THE PATIENT AND THE WIRE WAS "IMPOSSIBLE" TO REMOVE. THEY HAD TO REMOVE THE CATHETER AND WIRE TOGETHER TO START ALL OVER AGAIN. IT WAS FURTHER NOTED THAT THERE WERE TEARS ON THE CATHETER. 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 6991122 ↗MalfunctionSep 25, 2017Fracture; Fracture
A CXI SUPPORT CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, THE CATHETER FRACTURED WHEN PULLING IT BACK 90CM IN THE SUPPORT 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 Known Impact Or Consequence To Patient
MAUDE report 6892028 ↗MalfunctionSep 20, 2017Material Separation; Material Separation
A CXI SUPPORT CATHETER WAS USED IN A LOWER LEG ANGIOGRAM. IT WAS REPORTED, WHEN USING THE CATHETER THE HUB FELL OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 6879024 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.