Carey Alzate Coons G27044Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002270442), received between Nov 10, 2016 and Apr 26, 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 18, 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.

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

  CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER. THE RED HUB OF THE DEVICE DETACHED AT AN UNSPECIFIED TIME FOLLOWING DEVICE PLACEMENT (MDR#1820334-2017-00767. . THE PATIENT UNDERWENT EXPLANT AND REPLACEMENT OF THE CATHETER DURING WHICH THE HUB OF THE NEW CATHETER DETACHED (MDR# 1820334-2017-00767) WHEN THE DOCTOR WAS PUSHING THE MALECOT TO FORM THE ANCHOR. THE FORCES APPLIED TO THE DEVICE AT THE TIME OF DETACHMENT ARE NOT KNOWN. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION. THIS IS ONE OF TWO EVENTS REPORTED BY THE PHYSICIAN. REFERENCE MDR NUMBERS 1820334-2017-00767 AND 1820334-2017-00768 FOR BOTH EVENTS. THE SAME PATIENT IS ASSOCIATED WITH BOTH EVENTS.

  Patient problems: No Code Available

  MAUDE report 6521628 ↗
• MalfunctionNov 10, 2016Break; Break

  IT WAS REPORTED DURING AN EXCHANGE, THE ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER WAS PLACED AND UPON PULLING THE PIECE IN THE MIDDLE IT BROKE, INSTEAD OF FORMING THE TULIP THE TIP CAME OFF. REPORTEDLY THE EVENT OCCURRED OUTSIDE OF THE PATIENT, THE TUBE WAS REMOVED AND ANOTHER DEVICE WAS PLACED WITH NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6093044 ↗