Carey Alzate Coons G02956Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002029569), received between Jul 19, 2017 and Mar 6, 2018 — classified as 1 injury, 1 malfunction.

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.

• InjuryMar 6, 2018Detachment Of Device Component; Detachment Of Device Component

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE TIP OF THE CAREY-ALZATE-COONS SINGLE LUMEN GASTROJEJUNOSTOMY CATHETER DISCONNECTED FROM THE REST OF THE DEVICE, AND IT COULD NOT BE PUT BACK IN PLACE. THE DOCTOR WAS ABLE TO PERFORM A TEMPORARY FIX, THE NATURE OF WHICH WAS NOT REPORTED; HOWEVER, THE PRODUCT PROBLEM ULTIMATELY NECESSITATED THE PLACEMENT OF A NEW JEJUNOSTOMY CATHETER. THE CUSTOMER REPORTEDLY BELIEVED IT WAS A PROBLEM WITH THE DEVICE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7318112 ↗
• MalfunctionJul 19, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A CAREY-ALZATE-COONS SINGLE LUMEN GASTROJEJUNOSTOMY CATHETER. THE END OF THE FEEDING TUBE REPORTEDLY SNAPPED OFF. THE CIRCUMSTANCES AND HANDLING CONDITIONS AT THE TIME OF EVENT ARE NOT KNOWN. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. A REPLACEMENT DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS RECEIVED AS OF THE DATE OF THIS REPORT. AFTER FURTHER REVIEW OF THE RECORD, IT WAS DETERMINED THAT IT SHOULD BE NOTED THAT AN INTERNATIONAL CUSTOMER REPORTED THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725081 ↗