Cook G09665Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002096653), received between Mar 26, 2018 and Mar 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT, UPON INSPECTION OF THE DEVICE FOR A BRONCHIAL ARTERY EMBOLIZATION PROCEDURE, RED COLORED FOREIGN MATTER OF AN UNKNOWN ORIGIN WAS FOUND INSIDE THE PRODUCT VIAL. THE CUSTOMER REFUSED TO USE THE PRODUCT ON ACCOUNT OF THE FOREIGN MATTER. THIS OBSERVATION WAS MADE PRIOR TO CONTACT WITH A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM. THE COMPLAINT PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER; HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION AND INVESTIGATION ARE ONGOING. NO FURTHER INFORMATION REGARDING THE INCIDENT WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7372437 ↗