G-Jet® Transgastric-Jejunal Feeding Device GJ-1830-45-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071135454), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 2, 2026Material Separation; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #S: MW5181810 AND MW5181811, IT WAS REPORTED THAT, "ON (B)(6) 2025 MY 18FR AMT G-JET LOW PROFILE FEEDING TUBE 3.0 STOMA LENGTH X 45 CM BALLOON ALL OF A SUDDEN EMPTIED AFTER ONLY HAVING THE TUBE FOR TWO WEEKS AND TWO DAYS, IT WAS PLACED ON (B)(6) 2025 AT THE (B)(6) CLINIC BY DR. (B)(6) THROUGH ENDOSCOPY. I REACHED OUT TO AMT ON (B)(6) 2025 ASKING FOR ANY REASONING ON WHY THIS HAPPENED THAT I COULD PROVIDE MY DOCTOR, AND THEY SAID I CAN SEND THE TUBE IN TO BE EXAMINED. I ASSUMED IT WAS A FLUKE, AND HAD IT EXCHANGED ON (B)(6) 2025 FOR THE SAME TYPE OF TUBE. THE TUBE PLACED (B)(6) 2025 ALL OF A SUDDEN HAD THE SAME PROBLEM WITH THE BALLOON ALL OF A SUDDEN EMPTYING AND NOT RETAINING WATER ON (B)(6) 2025. I HAD THE 2ND BROKEN AMT G-JET BUTTON REMOVED (B)(6) 2025 AND REPLACED WITH AN AVANOS GJ TUBE UNTIL AMT CAN FIX THIS ISSUE. I AM SENDING THE FIRST TUBE THAT BROKE TO AMT FOR REVIEW BUT I DO HAVE THE SECOND TUBE THAT WAS PLACED (B)(6) 2025 AND REMOVED (B)(6) 2025 IN MY POSSESSION WITH THE ORIGINAL BOX IF THE FDA WOULD LIKE TO REVIEW IT. THE TUBE HAS NO SEAL AROUND THE GASTRIC HOLES, AND WHEN IT IS FILLED, IT IMMEDIATELY LEAKS OUT AROUND THE SEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489773 ↗

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