G-Jet® Transgastric-Jejunal Feeding Device GJ-1412-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071101442), received between Jun 14, 2017 and Jun 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.

• MalfunctionJun 14, 2017Loss of or Failure to Bond; Material Integrity Problem; Physical Property Issue; Loss of or Failure to Bond; Material Integrity Problem; Physical Property Issue

  AS REPORTED: DURING TUBE FEEDING THROUGH GJ TUBE, THE HARDENED DISC ON TOP OF THE SILICONE POT ON THE J-SIDE DISCONNECTED AND PREVENTED THE USE OF THIS PORT FROM FEEDING TUBE CONNECTION. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF GJ TUBE AND REINSERTION OF A NEW GJ TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639596 ↗

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