CXI G50002Recalls & reported problems
Cook Incorporated · CXI Support Catheter · Class 2
Quick summary
This Cook Incorporated CXI Support Catheter is a continuously flushed catheter used to support and drain vessels during procedures. The 30 reports mostly describe the catheter breaking apart, developing holes or perforations, kinking, or being hard to advance and remove, sometimes leaving a fragment in the patient. Six reports describe injuries and no deaths were reported. Most reports say the problem had no effect on the patient, and there are no recalls naming this device.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00827002500020), received between Jul 13, 2016 and Sep 10, 2021 — classified as 6 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Material Separation” (12 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 Separation12
- Kinked4
- Material Puncture/Hole4
- Material Perforation3
- Difficult to Remove2
- Failure to Advance2
- Contamination /Decontamination Problem1
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient13
- No Consequences Or Impact To Patient9
- No Code Available5
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION ON THE PATIENT OR PROCEDURE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12452261 ↗MalfunctionApr 29, 2021Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744700 ↗MalfunctionJun 10, 2020Material Perforation; Material Perforation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10138038 ↗MalfunctionMar 24, 2020Difficult to Remove; Difficult to Remove
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 9873981 ↗MalfunctionMay 30, 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 8653732 ↗InjuryMay 22, 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: Foreign Body In Patient
MAUDE report 8633357 ↗InjuryMay 1, 2019Fracture; Material Separation; Fracture; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8570440 ↗MalfunctionMar 21, 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 Consequences Or Impact To Patient
MAUDE report 8441075 ↗MalfunctionMar 8, 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 Consequences Or Impact To Patient
MAUDE report 8404532 ↗InjuryJan 29, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE INVOLVING A CHRONIC TOTAL OCCLUSION (CTO) OF THE FEMORAL AND POPLITEAL ARTERIES, A CXI SUPPORT CATHETER SEPARATED. THE LESION WAS REPORTED TO BE HEAVILY CALCIFIED AND THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE COMPLAINT DEVICE WAS REMOVED, THE TIP HAD ALLEGEDLY BROKEN OFF INSIDE THE PATIENT. THE TIP WAS RETRIEVED FROM THE PATIENT WITH THE LOOP OF A WIRE, PER THE INITIAL REPORTER. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 8284767 ↗MalfunctionJan 18, 2019Contamination /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 Known Impact Or Consequence To Patient
MAUDE report 8261009 ↗InjuryJan 18, 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: Foreign Body In Patient
MAUDE report 8260822 ↗MalfunctionDec 1, 2018Material Deformation; Material Deformation
IT WAS INITIALLY REPORTED THAT PRIOR TO A PERIPHERAL INTERVENTION PROCEDURE, A CXI SUPPORT CATHETER WAS FOUND TO BE KINKED. THIS WAS OBSERVED UPON REMOVAL FROM THE PROTECTIVE COVER. ADDITIONAL INFORMATION, PROVIDED ON 18NOV2018, REPORTED THAT THE KINK IN THE DEVICE RESULTED IN A SHARP POINT. 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. 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 8121836 ↗MalfunctionNov 28, 2018Material 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 Code Available
MAUDE report 8112065 ↗InjuryNov 8, 2018Material Separation; Material Separation
IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER AND AGE UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN WHICH A CXI SUPPORT CATHETER WAS USED. ACCESS WAS GAINED VIA THE SUPERFICIAL FEMORAL ARTERY (SFA). AS THE PHYSICIAN WAS ADVANCING THE COMPLAINT CXI OVER ANOTHER MANUFACTURER'S 0.014INCH GUIDE WIRE, THE CXI RUPTURED AT A PART NEAR THE HUB. NO RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE DEVICE. THE PHYSICIAN REPORTEDLY APPLIED SOME TORQUE TO THE DEVICE BUT NOT STRONGLY SINCE THE BLOOD VESSEL WAS NOT VERY CONSTRICTED. THE COMPLAINANT DENIED VESSEL TORTUOSITY AND CALCIFICATION. THE VESSEL WAS MILDLY STENOSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE COMPLAINT DEVICE WITH ANOTHER SUPPORT CATHETER. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, IT IS UNKNOWN IF THERE WERE ANY VESSEL SPASMS. THE HYDROPHILIC COATING OF THE COMPLAINT DEVICE WAS ACTIVATED ACCORDING TO THE PACKAGE INSERT. 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 Code Available
MAUDE report 8052817 ↗MalfunctionFeb 28, 2018Material Frayed; Kinked; Failure to Advance; Material Frayed; Kinked; Failure to Advance
IT WAS REPORTED THAT DURING TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO) LESION OF THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA), THE CXI SUPPORT CATHETER WAS UNABLE TO ADVANCE THROUGH THE LESION. THE TIP OF THE CATHETER WAS OBSERVED TO BE DAMAGED - FRAYED. IT WAS NOTED THAT THE PATIENT'S LESION WAS SEVERELY CALCIFIED, BUT NOT SEVERELY TORTUOUS. ANOTHER DEVICE WAS USED 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 7302902 ↗InjuryNov 15, 2017Material Separation; Material Separation
IT WAS REPORTED THAT DURING A LIMB SALVAGE PROCEDURE, THE CXI SUPPORT CATHETER BROKE. THE PATIENT HAD RIGHT LEG TOTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND ANTERIOR TIBIAL OCCLUSION, SEVERELY CALCIFIED, RECONSTITUTING AT DISTAL AT/DP. THE PHYSICIAN WAS SUCCESSFUL IN CROSSING THIS OCCLUSION RETROGRADE ACCESSING FROM DISTAL AT USING AN .018¿ 90CM CXI SUPPORT CATHETER (THIS REPORT) AND A V18 WIRE. A PEDAL SHEATH WAS INITIALLY USED AND THEN REMOVED, AND THE CXI SUPPORT CATHETER WAS ADVANCED SHEATH-LESS. WHEN REMOVING THE CATHETER, IT SEPARATED ALONG THE SHAFT INTO TWO PORTIONS. BOTH PORTIONS WERE SUCCESSFULLY RETRIEVED BY PULLING ON THE CATHETER UNTIL FULLY REMOVED. THE PHYSICIAN ALSO ACCESSED THE RIGHT LEG FROM THE LEFT GROIN, THROUGH AN UP AND OVER APPROACH USING A 6FR TERUMO DESTINATION SHEATH. THE SAME WIRE THAT WAS ADVANCED FROM PEDAL ACCESS WAS PULLED FROM THE RIGHT GROIN THROUGH THE 6FR TERUMO DESTINATION SHEATH. THE PHYSICIAN ALSO USED AN .018¿ 150CM CXI SUPPORT CATHETER (MEDWATCH NUMBER: 1820334-2017-03895) FROM THE RIGHT SIDE THROUGH THE 6FR TERUMO DESTINATION SHEATH OVER A SPARTACORE .014¿ WIRE BY ABBOTT. WHEN REMOVING THE CXI SUPPORT CATHETER, IT ALSO SEPARATED ALONG THE SHA
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7034895 ↗MalfunctionNov 7, 2017Failure to Advance; Device Contamination with Chemical or Other Material
THE DEVICE WAS USED FOR PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) FOR CTO (ISR) [CHRONIC TOTAL OCCLUSION] IN THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY) BY ANTEGRADE APPROACH FROM THE LEFT FA (FEMORAL ARTERY). THE CXI WAS ADVANCED WITH ANOTHER MANUFACTURER'S WIRE GUIDE. HOWEVER BECAUSE THE WIRE GUIDE COULD NOT PASS THROUGH THE CTO, THE WIRE GUIDE WAS CHANGED WITH A NEW WIRE GUIDE. WHEN THE USER WAS ADVANCING THE CXI COMBINED WITH THE SECOND WIRE GUIDE, IT WAS NOTED THAT THERE WAS "SOMETHING WRONG" WITH THE WIRE GUIDE AND IT RAPIDLY BECAME DIFFICULT TO MANIPULATE THE WIRE GUIDE INSIDE THE CXI. SUBSEQUENTLY, THE CXI WAS REMOVED FROM THE PATIENT. THE USER FLUSHED THE DEVICE AND FOUND THAT A GREEN UNKNOWN POWDER-LIKE SUBSTANCE CAME OUT FROM THE INNER LUMEN. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED, BUT ANOTHER CXI (0.035INCH) AND WIRE GUIDE WERE USED FOR THE PROCEDURE. 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 7006283 ↗MalfunctionNov 2, 2017Material Puncture/Hole
THEY PUT THE WIRE IN AND IT CREATED ITS OWN HOLE. IT WENT THROUGH THE SIDE OF THE CATHETER. THEY WERE UNABLE TO CROSS THE LESION. 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 6995768 ↗MalfunctionNov 1, 2017Disassembly
IT WAS REPORTED THAT THE WIRE GUIDE GOT STUCK IN THE CXI WHEN THE CXI WAS USED FOR THE PROCEDURE. IT WAS FURTHER NOTED THAT THE DEVICE UNRAVELED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 6994506 ↗MalfunctionNov 1, 2017Material Perforation; Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS REPORTED: APPROACH WAS GAINED FROM THE CFA (COMMON FEMORAL ARTERY). WHEN ANOTHER MANUFACTURER'S WIRE GUIDE WAS ADVANCED INTO THE CXI, IT PERFORATED THE CXI BETWEEN THE RADIOPAQUE MARKER IN THE DISTAL SITE AND THE CATHETER MATERIAL. THE DEVICES WERE THEN QUICKLY REMOVED FROM THE PATIENT. THE USER STOPPED USING THEM IN CONSIDERATION OF SAFE USE. IT WAS FURTHER CONFIRMED THAT THE TIP SEPARATED FROM THE CATHETER BETWEEN THE RADIOPAQUE MAKERBAND AND THE DISTAL BOND. THE CXI WAS REPLACED WITH ANOTHER MANUFACTURER'S MICROCATHETER TO COMPLETE THE PROCEDURE. 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 6994415 ↗MalfunctionNov 1, 2017Detachment Of Device Component
DURING A SFA (SUPERFICIAL FEMORAL ARTERY) PROCEDURE, ANOTHER MANUFACTURER'S GUIDE WIRE AND CATHETER WERE USED. WHEN USING THE CXI CATHETER, THE VALVE AND THE CATHETER SEPARATED. 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 6993353 ↗MalfunctionNov 1, 2017Hole In Material; Kinked; Material Perforation; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING ENDOVASCULAR TREATMENT OF A PERIPHERAL LESION, THE WIRE GUIDE PERFORATED THE CATHETER. A BIDIRECTIONAL APPROACH WAS SELECTED; THE DEVICE WAS INSERTED FROM THE LEFT FEMORAL ARTERY AND ANOTHER MANUFACTURER'S WIRE GUIDE WAS INSERTED IN A RETROGRADE FASHION, TO PERFORM PULL-THROUGH TECHNIQUE DUE TO SEVER CALCIFICATION IN THE LESION. AFTER THE PULL-THROUGH, THE CXI WAS ADVANCED AND PASSED THROUGH THE LESION TO CHANGE THE WIRE GUIDE. HOWEVER, THE WIRE GUIDE WAS CAUGHT AT A CERTAIN POINT INSIDE THE CATHETER DURING AN ATTEMPT AT CHANGING THE WIRE GUIDE, AND THE PHYSICIAN NOTICED THAT THE WIRE GUIDE PROTRUDED FROM THE CATHETER DURING MANIPULATION. A KINK AND A HOLE IN THE CATHETER WERE CONFIRMED AFTER REMOVAL OF THE DEVICE THOUGH; THE PROCEDURE WAS CONTINUED AND COMPLETED WITH NO PROBLEM. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6992698 ↗MalfunctionNov 1, 2017Stretched
THE PHYSICIAN ADVANCED A COMPETITOR'S WIRE GUIDE INTO THE DEVICE AND CONFIRMED THAT THE CATHETER STRETCHED. ANOTHER DEVICE WAS USED INSTEAD, AND COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6992689 ↗MalfunctionOct 31, 2017Melted; Difficult to Remove
THE CXI WAS USED WITH A COOK MICROPUNCTURE DEVICE AND A WIRE GUIDE FROM ANOTHER MANUFACTURER. WHEN THE PHYSICIAN TRIED TO TAKE OUT THE WIRE, IT WAS NOT POSSIBLE EVEN WITH MUCH FORCE. THE CXI TORE AND THE PHYSICIAN HAD TO TAKE OUT ALL OF THE PRODUCTS TOGETHER. IT WAS NOTED THAT ALL 3 PRODUCTS WERE MELTED TOGETHER. HOWEVER, NOTHING WAS LOST IN THE PATIENT'S VESSEL. THE INVESTIGATION FURTHER NOTED THAT THE DILATOR WAS MELTED ONTO THE CXI.THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL PROCEDURES AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6990481 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.