Carey Alzate Coons G27047Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002270473), received between Apr 26, 2017 and Apr 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 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.

• MalfunctionApr 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  COMPANY MEDICAL DEVICE SALES REPRESENTATIVE REPORTED THAT A ULTRATHANE CAREY-ALZATE-COONS DOUBLE LUMEN GASTROJEJUNOSTOMY CATHETER WAS BEING USED FOR DEMONSTRATION AND TEACHING PURPOSES. THE DEVICE MALECOT WAS OPENED AND CLOSED APPROXIMATELY SIX (6) CYCLES AFTER WHICH THE SUTURE WING DISCONNECTED FROM THE MALECOT. THIS RENDERED THE DEVICE UNUSABLE. THERE WAS NO PATIENT CONTACT, AND ACCORDINGLY NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION HOWEVER IT WAS NOT RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 6521697 ↗