Cook G26867Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002268678), received between Nov 20, 2017 and Aug 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Bent” (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

Recent adverse event reports

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

• InjuryAug 5, 2022Break; Break

  AS REPORTED, AT THE BEGINNING OF AN UNKNOWN PROCEDURE, A CATHETER INCLUDED WITH A CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE SEPARATED INTO TWO PIECES AS ANOTHER MANUFACTURER'S WIRE GUIDE WAS BEING WITHDRAWN, PRIOR TO INTRODUCER INSERTION. THE SEPARATED PORTION OF THE CATHETER MIGRATED TO THE LEFT ILIAC ARTERY. OPERATING TIME WAS EXTENDED, AND LOCAL ANESTHETIC WAS ADMINISTERED FOR SURGICAL REMOVAL OF THE SEPARATED FRAGMENT, USING LARGER "HEAVY-DUTY" INTRODUCERS AND A LASSO. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15176607 ↗
• MalfunctionNov 20, 2017Bent; Bent

  IT WAS REPORTED THAT PRIOR TO THE UTILIZATION OF THE DEVICE, UPON OPENING THE PACKAGE, THE PHYSICIAN NOTICED THAT THE CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE WAS BENT. THE DEVICE DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7046617 ↗