CXIRecalls & reported problems across all models
Cook Incorporated · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 323
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls
- 0
We found 34 models of CXI by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 323 adverse event reports in the FDA's MAUDE database, received between May 2, 2016 and Sep 30, 2026 — classified as 62 injuries, 261 malfunctions.
The most frequently reported specific device problem is “Material Separation” (94 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CXI problems
Device problems
- Material Separation94
- Break93
- Material Perforation24
- Detachment of Device or Device Component14
- Kinked13
- Difficult to Remove10
- Material Puncture/Hole10
- Stretched10
Patient problems
- No Clinical Signs, Symptoms or Conditions121
- No Known Impact Or Consequence To Patient74
- No Consequences Or Impact To Patient54
- No Code Available30
- Foreign Body In Patient29
- No Patient Involvement16
- Insufficient Information11
- Device Embedded In Tissue or Plaque8
CXI models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CXI G50002Catheter, continuous flush30 reports
- CXI G50003Catheter, continuous flush29 reports
- CXI G56553Catheter, continuous flush28 reports
- CXI G50001Catheter, continuous flush26 reports
- CXI G52547Catheter, continuous flush23 reports
- CXI G18373Catheter, continuous flush22 reports
- CXI G18376Catheter, continuous flush16 reports
- CXI G52546Catheter, continuous flush15 reports
- CXI G50004Catheter, continuous flush13 reports
- CXI G52543Catheter, continuous flush13 reports
- CXI G56551Catheter, continuous flush13 reports
- CXI G23162Catheter, continuous flush12 reports
- CXI G52542Catheter, continuous flush11 reports
- CXI G52544Catheter, continuous flush9 reports
- CXI G18371Catheter, continuous flush8 reports
- CXI G56552Catheter, continuous flush8 reports
- CXI G23160Catheter, continuous flush7 reports
- CXI G52545Catheter, continuous flush6 reports
- CXI G56550Catheter, continuous flush6 reports
- CXI G23163Catheter, continuous flush5 reports
- CXI G18372Catheter, continuous flush4 reports
- CXI G23859Catheter, continuous flush3 reports
- CXI G18367Catheter, continuous flush2 reports
- CXI G18369Catheter, continuous flush2 reports
- CXI G18370Catheter, continuous flush2 reports
- CXI G23860Catheter, continuous flush2 reports
- CXI G18368Catheter, continuous flush1 report
- CXI G18377Catheter, continuous flush1 report
- CXI G18378Catheter, continuous flush1 report
- CXI G23861Catheter, continuous flush1 report
- CXI G23862Catheter, continuous flush1 report
- CXI G23863Catheter, continuous flush1 report
- CXI G23864Catheter, continuous flush1 report
- CXI G23865Catheter, continuous flush1 report
Recent CXI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951625 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210548 ↗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 ↗MalfunctionFeb 27, 2026Break
AS REPORTED, DURING A PROCEDURE INVOLVING ARTERIAL RECANALIZATION FOR AN OCCLUSION OF THE LEFT LOWER EXTREMITY, A CXI SUPPORT CATHETER SEPARATED. UNDER FLUOROSCOPIC GUIDANCE, ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY FOR A CONTRALATERAL APPROACH TO THE LEFT LOWER EXTREMITY. THE ANATOMY WAS REPORTEDLY CALCIFIED. SIGNIFICANT RESISTANCE WAS ENCOUNTERED AS THE USER ATTEMPTED TO ADVANCE AN UNSPECIFIED STANDARD WIRE GUIDE OVER THE BIFURCATION TO THE LEFT LOWER EXTREMITY, MAKING ADVANCEMENT DIFFICULT. THE USER THEN ATTEMPTED TO USE THE CXI CATHETER FOR RECANALIZATION; HOWEVER, REPEATED ATTEMPTS TO ADVANCE THE CATHETER WERE UNSUCCESSFUL. ANOTHER MANUFACTURER¿S BALLOON CATHETER WAS THEN USED TO ATTEMPT PRE-DILATION OF THE VESSEL. UPON ATTEMPTED ADVANCEMENT OF THE BALLOON, ANGIOGRAPHY REVEALED THAT THE WIRE GUIDE WAS NOT ADVANCING, AS A SECTION OF THE CXI CATHETER HAD SEPARATED IN THE VESSEL. THE SEPARATED FRAGMENT WAS REMOVED WITH A BASKET WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 24470313 ↗MalfunctionJan 16, 2026Break
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED PRIOR TO PATIENT CONTACT AS IT WAS INSERTED INTO A SHEATH AND ADVANCED OVER A WIRE GUIDE. 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 24093397 ↗InjuryDec 30, 2025Break; Break
AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, THE TIP OF A CXI SUPPORT CATHETER SEPARATED INSIDE OF THE PATIENT. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL ARTERY AND PROFUNDA. ANOTHER MANUFACTURER¿S SHEATH AND ANOTHER MANUFACTURER¿S WIRE WERE USED DURING THE PROCEDURE. THE HYDROPHILIC COATING WAS REPORTEDLY ACTIVATED. RESISTANCE WAS ENCOUNTERED DURING INSERTION/ADVANCEMENT OF THE CATHETER, AS THE LESION WAS CALCIFIED. DURING REMOVAL OF THE OTHER MANUFACTURER¿S 0.014-INCH WIRE GUIDE, THE TIP OF THE CATHETER SEPARATED ¿FROM THE DISTAL MARKER FORWARD¿. PER THE REPORTER, IT IS UNCLEAR IF THE WIRE WAS PULLED FIRST OR IF THE CATHETER WAS PULLED WITH THE WIRE INSIDE. A POWER INJECTOR WAS NOT USED WITH THE CATHETER. THE USER WAS UNABLE TO CROSS THE LESION; THEREFORE, THE PROCEDURE WAS NOT COMPLETED. THE SEPARATED FRAGMENT REMAINS IN THE PATIENT, WITHIN A LATERAL BRANCH OF THE PROFUNDA. PER THE REPORTER, 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 23926754 ↗MalfunctionDec 4, 2025Difficult 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23715245 ↗MalfunctionNov 26, 2025Break; Break
AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, A CXI SUPPORT CATHETER SEPARATED. THE HYDROPHILIC COATING WAS ACTIVATED, AND THE CATHETER WAS FLUSHED PER THE INSTRUCTIONS FOR USE. THE USER ATTEMPTED TO ADVANCE THE CATHETER OVER A 180-CENTIMETER COOK ROSEN WIRE; HOWEVER, THE CATHETER BECAME STUCK HALFWAY ON THE WIRE, PRIOR TO REACHING THE SHEATH. THE CATHETER DID NOT ENTER THE PATIENT'S BODY. THE PHYSICIAN THEN TRIED TO REMOVE THE CATHETER FROM THE WIRE, BUT THE CATHETER WAS STILL STUCK. THE PHYSICIAN THEN USED ADDITIONAL FORCE IN AN ATTEMPT TO REMOVE THE CATHETER FROM THE WIRE, AT WHICH POINT THE CATHETER SEPARATED INTO TWO PIECES, APPROXIMATELY TEN CENTIMETERS FROM THE DISTAL TIP. ADDITIONAL PIECES OF THE CATHETER REPORTEDLY BROKE OFF WHEN REMOVING THE REMAINING PORTION OF THE CATHETER FROM THE WIRE. AFTER THE SEPARATED CATHETER WAS REMOVED FROM THE WIRE, THE WIRE, WHICH WAS NOT REMOVED FROM THE PATIENT, WAS CLEANED AND CHECKED, AND ANOTHER CXI OF THE SAME TYPE WAS USED OVER THE SAME WIRE TO COMPLETE THE PROCEDURE WITHOUT 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 23660070 ↗MalfunctionNov 17, 2025Break; Break
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, A CXI SUPPORT CATHETER SEPARATED. PER THE REPORTER, THE CXI WAS OVER AN UNKNOWN WIRE AND INSIDE OF ANOTHER MANUFACTURER'S 4-FRENCH CATHETER. DURING THE PROCEDURE, THE CXI "SNAPPED" IN TWO. WHEN THE USER REMOVED THE OTHER MANUFACTURER'S CATHETER, THE SEPARATED PORTION OF THE CXI WAS REPORTEDLY OUTSIDE OF THE SHEATH; THEREFORE, THE USER WAS ABLE TO MANUALLY REMOVE THE SEPARATED FRAGMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572452 ↗MalfunctionNov 14, 2025Break; Break
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE DISTAL TIP OF A CXI SUPPORT CATHETER "BROKE IN TWO" OUTSIDE OF THE PATIENT DURING REMOVAL OF THE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23559776 ↗InjuryNov 4, 2025Break; Break
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 23468789 ↗MalfunctionOct 24, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 24OCT2025. THE PROCEDURE INVOLVED MULTIPLE INTERVENTIONS INCLUDING INTRAVASCULAR LITHOTRIPSY, PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY, AND STENT PLACEMENT. THE PATIENT HAD MULTI-LEVEL AORTOILIAC OCCLUSIVE DISEASE OF THE RIGHT LOWER EXTREMITY, AND THE RIGHT SUPERFICIAL FEMORAL AND POSTERIOR TIBIAL ARTERIES WERE OCCLUDED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY TO TARGET THE RIGHT LOWER EXTREMITY, DOWN TO THE POSTERIOR TIBIAL ARTERY. THE CATHETER WAS ADVANCED THROUGH ANOTHER MANUFACTURER¿S 45-CENTIMETER SHEATH, AND MULTIPLE WIRES WERE USED DURING THE PROCEDURE. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF THE CATHETER. A POWER INJECTOR WAS NOT USED. THE DEVICE SEPARATED IN THE MIDDLE OF THE PROCEDURE. IT IS UNKNOWN WHAT WAS ATTACHED TO THE HUB AT THE TIME OF THE EVENT. THE CATHETER WAS MANUALLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH IN-LINE FLOW VIA PERONEAL ARTERY RUNOFF WITH MULTI-PHASIC PEDAL DOPPLER SIGNALS AFTER THE INTERVENTIONAL PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378661 ↗MalfunctionOct 22, 2025Break; Break
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 23357706 ↗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 ↗MalfunctionAug 15, 2025Break; Break
AS REPORTED, PRIOR TO PATIENT CONTACT DURING PREPARATION FOR A LEG ANGIOGRAM, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. THE CATHETER WAS FLUSHED NORMALLY, AND THE HUB WAS WIPED WITH SALINE. AS THE USER ATTEMPTED TO LOAD THE DEVICE ONTO ANOTHER MANUFACTURER¿S 0.014-INCH WIRE, THE VERY DISTAL TIP OF THE CATHETER SEPARATED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY 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 22814772 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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