CXI G23163Recalls & reported problems
Cook Incorporated · CXI Support Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002231634), received between Jan 11, 2024 and May 5, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Material Deformation2
- Difficult to Advance1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2025Break; Break
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED AND BECAME EMBEDDED WITHIN THE PATIENT¿S VESSEL. ATTEMPTS TO RETRIEVE THE SEPARATED TIP WERE UNSUCCESSFUL, AND THE FRAGMENT REMAINS IN THE PATIENT. THE PATIENT WAS HOSPITALIZED; HOWEVER, THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 21961649 ↗MalfunctionApr 2, 2025Break; Break
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21755845 ↗MalfunctionJan 6, 2025Break; Break
AS REPORTED, PRIOR TO USE FOR A PERIPHERAL ANGIOGRAM, A CXI SUPPORT CATHETER'S TIP WAS "CRACKED AND BROKEN". THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CXI CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078562 ↗MalfunctionJun 18, 2024Material Puncture/Hole; Difficult to Advance; Material Deformation; Material Puncture/Hole; Difficult to Advance; Material Deformation
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 19562056 ↗MalfunctionJan 11, 2024Break; Material Deformation; Break; Material Deformation
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 18495849 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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