AMT Mini Extension Set E6-1222-ISOSAFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842071140069), received between Nov 5, 2025 and Sep 11, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K110804, K123716, K142989, K945618); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Break; Fluid/Blood Leak; Difficult to Open or Close

  I have an AMT GJet tube (18Fr, 3.5, 45 length). I am on 18hr continuous J-tube feeds. Ireceive some medications via my G-tube. I was connected to both G and J extensionswhen I started throwing up, and the tip of the G extension broke off into the tube. Icalled the interventional radiology and GI teams, who directed me to the ED. Since theG port could not be shut, I was leaking gastric contents out and developed a stomachacid burn on my hypogastric region. Over the next couple weeks, two more Gextensions broke into the port. I had another ED visit, then ultimately needed acomplete tube replacement on (b)(6) 2026 as the valve was broken (secondary to theextension breaking). I required ED & medical help to prevent further stomacomplications and infection, and to minimize risk of metabolic or hemodynamicinstability as I receive medications via my tube to prevent hypoglycemia &hypotension. I had several episodes of severe hypoglycemia due to leakage of the Gport (when pushing Glycosade) and after the tube replacement, had two episodes ofhypotension (67/37 and 74/45). I no longer have the three broken extensions as AMTrequested that I ship them back to them, so I did. The extensions are

  Patient problems: Gastritis; Hypoglycemia; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 50732447 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Feeding Problem

  MAUDE report 50212873 ↗
• MalfunctionMay 21, 2026Break; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: MW5186451, IT WAS REPORTED THAT, "MY BABY, (B)(6), HAS AN AMT GJET TUBE. THE G CONNECTORS, (NOT THE J'S), KEEPING REPEATEDLY BREAKING AND GETTING STUCK INSIDE THE PORT. THE EXTENSION THAT KEEPS BREAKING IS CALLED 12" RIGHT ANGLE FEEDING SET WITH DUAL ENFIT Y-PORT. MY BABY IS CONSTANTLY BEING PUT TO SLEEP TO GET A NEW ONE. WE AREN'T SURE HOW OR WHY IT'S HAPPENING. WE ARE SCREWING IT IN PROPERLY (LINE IT UP WITH THE LINE AND TURN IT CLOCKWISE TO LOCK). WE ALWAYS MAKE SURE IT'S SECURE AND LOCKED IN PLACE. THE J CONNECTORS ARE DIFFERENTLY QUALITY THAN THE G'S. I BELEIVE IT'S BREAKING BECAUSE THE G CONNECTORS ARE CHEAP POOR-QUALITY PLASTIC. WE CAME ACROSS MULTIPLE POSTS WITH THIS HAPPENING AND I POSTED AS WELL. IT SEEMS LIKE MULTIPLE REPORTS HAVE BEEN MADE BUT NOTHING EVER GETS DONE ABOUT IT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244364 ↗
• MalfunctionMay 21, 2026Break; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #S: MW5186468 AND MW5186469, IT WAS REPORTED THAT, "THE AMT MINI ENTERAL EXTENSION SET IS BREAKING WHILE IN THE PATIENT'S G TUBE. THE PART OF THE AMT THAT INSERTS INTO THE G TUBE IS BREAKING OFF WHILE THE CONNECTION TUBING IS BEING TAKEN OFF AND ON THE PATIENT. THIS HAS HAPPENED TWICE TO THIS SAME PATIENT WITHIN A WEEK. THIS EVENT WAS REPORTED TO THE AMT VENDOR REPRESENTATIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243758 ↗
• MalfunctionNov 5, 2025Break; Leak/Splash; No Apparent Adverse Event; Break; Leak/Splash; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: MW5176512, IT WAS REPORTED THAT, "THE PART OF THE EXTENSION THAT GOES INTO THE G PORT OF THE G-JET IS BREAKING OFF AND IT IS UNABLE TO BE REMOVED. WHEN THIS HAPPENS, THEY ARE UNABLE TO CLOSE THE PORT AND GASTRIC CONTENTS QUICKLY LEAK OUT. ULTIMATELY IT REQUIRES URGENT SURGICAL INTERVENTION TO REPLACE THE G-JET. DAD NOTES THAT HE WAS ABLE TO GET THE PIECE OUT ONE OF THE TIMES, BUT THE OTHER TWO TIMES REQUIRED PLACEMENT OF A NEW G-JET." ITEM DISCARDED BY MEDICAL PROVIDERS AT TIME OF INTERVENTION AND UNABLE TO RETURN. WRITER MANAGES PRODUCT COMPLAINT PLATFORM AND THIS IS THE 4TH COMPLAINT FOR THIS ITEM THIS YEAR. THIS IS THE FIRST TIME SIGNIFICANT MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE BUT RISK OF HARM AND BEING UNABLE TO REMOVE THE PIECES ONCE BROKEN WERE PRESENT IN 2 OF THE OTHER COMPLAINTS ENTERED AS WELL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479581 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110804, K123716, K142989, K945618. One submission often covers many models, so check the product and lot details in each record.

• Z-0819-2025 · Nov 26, 2024 · Completed
  AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
• 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