G-Jet® Transgastric-Jejunal Feeding Device GJ-1415-15-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071116750), received between Feb 8, 2022 and Feb 8, 2022 — 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.

• DeathFeb 8, 2022Adverse Event Without Identified Device or Use Problem

  ORIGINAL REPORTER INDICATED THAT A LOW-PROFILE G-JET WAS PLACED IN A (B)(6) OLD, (B)(6) KG PATIENT ON (B)(6) 2021. ON THE WEEKEND OF (B)(6) 2022, IT WAS NOTED THAT THE PATIENT EXPERIENCED A TUBE PERFORATION THROUGH THE GUT AND THE PATIENT PASSED AWAY. THE PATIENT WEIGHT WAS PROVIDED AS (B)(6) KG AT THE TIME THE PERFORATION OCCURRED. AWAITING ADDITIONAL INFORMATION REGARDING EVENT AND DETAILS OF OCCURRENCE. THERE HAS BEEN NO INDICATION OF MALFUNCTION OR DEFECT AT THIS TIME.

  Patient problems: Perforation

  MAUDE report 13486473 ↗

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