G-Jet® Transgastric-Jejunal Feeding Device GJ-1825-45-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071117429), received between Feb 7, 2025 and Feb 7, 2025 — classified as 1 malfunction.

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.

• MalfunctionFeb 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF #:MW5163707, IT WAS REPORTED THAT THE,"THE "BALLOON" THAT HOLDS MY SON'S GASTRIC-JEJUNIAL FEEDING TUBE IN PLACE HAS BROKEN REPEATEDLY. MY SON IS FED CONTINUOUSLY VIA A FEEDING PUMP AND A GASTRIC-JEJUNAL FEEDING TUBE. THE TUBE USED TO BE CHANGED OUT AFTER ONE YEAR. STARTING AROUND LAST SUMMER THE BALLOONS ON THE FEEDING TUBES STARTED BREAKING APPROXIMATELY ONCE PER MONTH. HE WAS USING THE AVANOS MIC-KEY BUTTON, MANUFACTURED IN MEXICO. HE HAD USED A MIC-KEY BUTTON FOR ABOUT 25 YEARS. WE USED TO REPLACE IT ONCE PER YEAR. THEN THE BALLOONS ON THE MIC-KEY BUTTONS STARTED BREAKING. WE REPLACED THE MIC-KEY BUTTON SEVERAL TIMES THINKING IT WAS A FLUKE, THAT IT WOULD NOT HAPPEN AGAIN. WE TRIED HAVING THE DOCTOR PUT LESS WATER INTO THE BALLOON, THAT DID NOT INCREASE THE LONGEVITY. WE SWITCHED TO A DIFFERENT BUTTON, THE APPLIED MEDICAL TECHNOLOGY G-J JET, THINKING THAT WOULD SOLVE THE PROBLEM. THE BALLOON BROKE AFTER ABOUT 4 WEEKS. WE REPLACED AND IT SOON BROKE AGAIN. WE SWITCHED BACK TO THE AVANOS MIC-KEY BUTTON. THE BALLOON BROKE AFTER ABOUT 2 WEEKS. MY SON IS 30 YEARS OLD. HE HAS ALWAYS HAD A FEEDING TUBE. THE BALLOONS BREAKING IS TOTALLY NEW. THERE ARE NO O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21336795 ↗

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