G-Jet® Transgastric-Jejunal Feeding Device GJ-1430-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842071101824), received between Jun 7, 2022 and Mar 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF #(B)(4): , IT WAS REPORTED THAT "THIS REGISTERED NURSE (RN) WAS PASSED ALONG INFORMATION IN REPORT THAT PATIENT'S GJ TUBE WAS DISLODGED. WAS TOLD PATIENT HAD INCREASED AGITATION AND MOVEMENT EARLY IN THE MORNING AND RN ENTERED INTO THE ROOM TO ADMINISTER MEDICATIONS AND GJ TUBE WAS DISLODGED. RN PAGED TEAM TO THE BEDSIDE AND DOCTOR CAME TO THE BEDSIDE TO ASSESS AND PLACED ORDERS. SHOWED MALFUNCTION OF GJ TUBE BALLOON. PATIENT TO RETURN TO OR TO HAVE GJ TUBE REPLACED AS THIS IS A SURGICAL PROCEDURE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943636 ↗
• MalfunctionJun 7, 2022Loose or Intermittent Connection; Material Rupture; Therapeutic or Diagnostic Output Failure

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: (B)(4), "DESCRIBE THE EVENT OR PROBLEM: G-JET TUBE BALLOON RUPTURED CAUSING THE TUBE TO BE LOOSE. THE TUBE REMAINS IN THE POST-PYLORIC POSITION. THE TUBE WAS SECURE TO THE ABDOMINAL WALL WITH TAPE. TUBE ULTIMATELY REQUIRED REPLACEMENT."

  Patient problems: Failure of Implant

  MAUDE report 14626125 ↗
• MalfunctionJun 7, 2022Material Rupture; Detachment of Device or Device Component

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #:(B)(4), "DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS BEING TURNED FOR A DIAPER CHANGE AND GASTROJEJUNOSTOMY (GJ) WAS NOTED TO BE SITTING ABOUT 1 INCH OUT OF ABDOMEN. PATIENT REQUIRED A KUB AND SURGICAL REPLACEMENT OF GJ TUBE. BALLOON RUPTURED."

  Patient problems: Insufficient Information

  MAUDE report 14625455 ↗

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