CXI G23861Recalls & reported problems
Cook Incorporated · CXI Support Catheter · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002238619), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Break; Break
AS REPORTED, DURING AN ANGIOPLASTY OF THE TIBIAL ARTERIES VIA CONTRALATERAL ACCESS IN THE COMMON FEMORAL ARTERY, A CXI SUPPORT CATHETER SEPARATED. THE CATHETER WAS ADVANCED THROUGH A COOK 5-FRENCH, 90-CENTIMETER ANSEL SHEATH, OVER ANOTHER MANUFACTURER¿S 0.014-INCH WIRE GUIDE. THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF THE CATHETER. TOWARD THE END OF THE PROCEDURE, THE CATHETER SEPARATED BETWEEN THE HUB AND CATHETER. A POWER INJECTOR WAS NOT USED WITH THE DEVICE. THE USER REPORTEDLY THEN CUT THE CATHETER WITH A BLADE TO MAINTAIN WIRE ACCESS, AND THE CATHETER WAS REPLACED WITH ANOTHER CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. THE DEVICE WAS RETURNED TO COOK ON 10FEB2025. PHOTOS SHOW THAT THE DEVICE WAS SEPARATED JUST BELOW THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21423630 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.