G-Jet® Transgastric-Jejunal Feeding Device GJ-1417-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071101565), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 malfunction.

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

• MalfunctionNov 19, 2020Break

  PER THE INITIAL REPORTER'S ORIGINAL REPORT (REPORT #: (B)(4)): "DESCRIBE THE EVENT OR PROBLEM: PATIENT HAD AMT G-JET TUBE PLACED AS AN INPATIENT ON THREE MONTHS AGO. REPORTED BY NURSING STAFF THAT THE WHITE PLASTIC RING INSIDE OF THE JEJUNAL PORT BROKE OFF IN EARLY (B)(6). TUBE WAS REPLACED ON THE NEXT DAY DUE TO INABILITY TO FEED THE CHILD. PER GI MD PROGRESS NOTES: MOTHER OF PATIENT WONDERS IF THERE IS UTILITY IN REACHING OUT TO OTHER PARENTS OF CHILDREN WITH GJ TUBES TO SEE IF THIS IS A COMMON OCCURRENCE. PATIENT'S MOTHER RELAYS THAT HAS SPOKEN WITH OTHER MOTHERS IN SUPPORT GROUP AND FEELS THAT AMT PRONE TO BREAKING. SHE REQUESTS THAT IN FUTURE WHEN GJ TUBE EXCHANGE NEEDED, THAT MICKEY GJ TUBE BE USED INSTEAD. DOCTOR REASSURED PATIENT'S MOTHER THAT GJ TUBE WILL BE SAVED IN ORDER TO FILE REPORT WITH COMPANY. THIS EVENT IS RELATED TO THE SAME PATIENT FOR MEDWATCH REPORT (B)(4). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : SMALL INTESTINAL ENDOSCOPY CONVERSION OF PERCUTANEOUS GASTROSTOMY TUBE TO PERCUTANEOUS JEJUNOSTOMY TUBE [(B)(4)]. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING."

  Patient problems: Missed Dose

  MAUDE report 10871653 ↗

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