Skip to content

CXI G23860Recalls & reported problems

Cook Incorporated · CXI Support Catheter · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002238602), received between Jun 21, 2019 and Mar 10, 2022 — classified as 2 malfunctions.

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.

Most reported problems

Device problems

  • Break1
  • Fluid/Blood Leak1
  • Material Perforation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 10, 2022Break; Material Perforation; Break; Material Perforation

    DEVICE WAS RETURNED TO COOK ON 15MAR2022. THE TIP OF THE CATHETER WAS PARTIALLY SEPARATED/FRACTURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13720659 ↗
  • MalfunctionJun 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

    AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE LEFT LOWER EXTREMITY FOR LIMB SALVAGE, INVOLVING A MALE PATIENT APPROXIMATELY 80 YEARS OF AGE, A CXI SUPPORT CATHETER SEPARATED AT THE HUB AND SUBSEQUENTLY SEPARATED INTO SEVERAL PIECES UPON REMOVAL. PEDAL ACCESS WAS OBTAINED BEHIND THE ANKLE BONE AND ANOTHER MANUFACTURER'S WIRE WAS USED. THE PATIENT'S ANATOMY WAS REPORTEDLY VERY CALCIFIED. WHILE BACKING THE CATHETER OFF THE WIRE BY PULLING ON THE HUB, THE HUB SEPARATED FROM THE SHEATH. RESISTANCE WAS REPORTED UPON REMOVAL OF THE DEVICE. THERE WAS NO BLOOD LOSS. THE FITTING WAS NOT ATTACHED TO ANOTHER DEVICE AT THE TIME OF SEPARATION. A "KELLY CLAMP" WAS USED TO PULL THE CATHETER BACK TO MAINTAIN ACCESS WITH THE OTHER MANUFACTURER'S WIRE. REPORTEDLY, WHILE FORCEFULLY PULLING THE CATHETER WITH THE CLAMP, THE CATHETER BROKE INTO SEVERAL PIECES. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. SOME OF THE PIECES WERE DISCARDED IN THE PROCEDURE ROOM. THIS EVENT IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). DURING THE SAME PROCEDURE, ANOTHER CXI SUPPORT CATHETER WAS USED IN THE PEDAL ACCESS SITE. ONCE THE DEVICE WAS REMOVED AND FLUSHED, IT WAS NOTED THAT THE DEVICE WAS LEAKING NEAR

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8723890 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.