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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071101480), received between Sep 14, 2021 and Sep 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionSep 14, 2021Material Rupture

  PER THE ORIGINAL REPORTER'S REPORT #: MW5102495, IT WAS REPORTED "TO IR (B)(6) 2021 FOR GASTROJEJUNOSTOMY CATHETER CHECK AND EXCHANGE. SHORTLY LATER (NOTED LESS THAN ONE HOUR), IT WAS DISCOVERED THE BALLOON OF THE TUBE HAD RUPTURED AND PT. HAD TO RETURN TO IR SUITE FOR GASTROJEJUNOSTOMY CATHETER CHECK AND EXCHANGE NOTING THE CATHETER WAS FAULTY. FDA SAFETY REPORT ID# (B)(4)."

  Patient problems: Insufficient Information

  MAUDE report 12468927 ↗

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