Cook G05933Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002059337), received between Sep 25, 2017 and Sep 25, 2017 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 25, 2017Loose or Intermittent Connection

  IT WAS REPORTED DURING THE PATIENT'S AORTIC VALVE IMPLANTATION, AT THE MOMENT OF GUIDE WITHDRAWAL, ONE ACCESS WAY OF THE CATHETER BECAME LOOSE. AS A RESULT, IT WAS NECESSARY TO USE ANOTHER CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6891265 ↗
• MalfunctionSep 25, 2017Break

  IT WAS REPORTED DURING THE PATIENT'S VASCULAR SURGICAL PROCEDURE, DURING PUNCTURE, WHEN THE PHYSICIAN WAS REMOVING THE WIRE GUIDE, THE CONNECTOR OF ONE LUMEN BROKE FREE. AS A RESULT, THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO SUCCESSFULLY FINISH THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING AS A RESULT OF THIS INCIDENT AND NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6890946 ↗