G-Jet® Transgastric-Jejunal Feeding Device GJ-1412-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071101428), received between Mar 4, 2021 and Mar 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionMar 4, 2021Break

  PER THE ORIGINAL UF REPORT #: (B)(4): "DESCRIBE THE EVENT OR PROBLEM: PER MOTHER OF PATIENT, PLASTIC RING THAT HOLDS THE FEEDING TUBE INTO THE JEJUNAL PORT OF THE G-J BUTTON BROKE AND FELL OUT. NO LONGER ABLE TO FEED CHILD AND HAD TO BE REPLACED URGENTLY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : SMALL INTESTINAL ENDOSCOPY WITH CONVERSION OF PERCUTANEOUS GASTROSTOMY TUBE TO PERCUTANEOUS JEJUNOSTOMY TUBE ((B)(4))]"

  Patient problems: Insufficient Information

  MAUDE report 11417562 ↗

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