G-Jet® Transgastric-Jejunal Feeding Device GJ-1410-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071101381), received between Oct 12, 2017 and Oct 12, 2017 — classified as 1 death.

1 other recall cover devices cleared under the same FDA submission (K110804, K123716); they may or may not involve this specific model.

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.

• DeathOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON THE REPORTED INFORMATION FROM THE DOCTOR, THE DOCTOR WAS INVOLVED IN AN OPERATION WITH A (B)(6) PATIENT WITH DOWN SYNDROME. THE PATIENT HAD MANY HEALTH FACTORS AT PLAY, INCLUDING DUODENAL ATRESIA. THE DOCTOR WENT INTO THE PLACEMENT WITH KNOWLEDGE THAT THERE WAS A HIGH RISK DUE TO THE PATIENT'S SITUATION, BUT HAD DECIDED THAT ATTEMPTING THE PROCEDURE WAS STILL THE BEST OPTION. THE PATIENT EXPERIENCED A JEJUNAL PERFORATION FROM THE PLACEMENT PROCEDURE AS CONFIRMED BY THE RADIOLOGIST. THE RADIOLOGIST INVOLVED WITH THE CASE DOES NOT BLAME THE AMT DEVICE AND ONLY PROVIDED THE INFORMATION TO AMT FOR REPORTING PURPOSES. BASED ON THE DOCTOR'S ANALYSIS, HE BELIEVES THAT THE G-JET DEVICE DID NOT CAUSE THE PERFORATION AND IT WAS THE PATIENT'S OTHER FACTORS THAT LEAD TO THE ISSUES EXPERIENCED FROM THE PLACEMENT PROCEDURE.

  Patient problems: Bowel Perforation; Injury; Perforation

  MAUDE report 6945160 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110804, K123716. One submission often covers many models, so check the product and lot details in each record.

• Z-1497-2016 · Jan 26, 2016 · Terminated
  AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stoma