AMT Mini ONE Extension SetRecalls & reported problems across all models

We found 5 models of AMT Mini ONE Extension Set by Applied Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between May 26, 2021 and Aug 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AMT Mini ONE Extension Set recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 19, 2017Terminated

   Expired expiration dates are listed on the pouches.

   Z-1224-2017 · Root cause: Employee error · Recall details · FDA record ↗

Most reported AMT Mini ONE Extension Set problems

AMT Mini ONE Extension Set models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMT Mini ONE® Extension Set E8-1222

  Tubes, Gastrointestinal (And Accessories)
  1 recall0 reports
• AMT Mini ONE® Extension Set E8-1255-ISOSAF

  Gastrointestinal Tubes With Enteral Specific Connectors
  1 report
• AMT Mini ONE® Extension Set E8-2455-ISOSAF

  Tubes, Gastrointestinal (And Accessories)
  1 report
• AMT Mini ONE® Extension Set 8-1255

  Gastrointestinal Tubes With Enteral Specific Connectors
  1 report
• AMT Mini ONE® Extension Set 8-2455

  Gastrointestinal Tubes With Enteral Specific Connectors
  1 report

Recent AMT Mini ONE Extension Set adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDSUN REPORT #:(B)(4), IT WAS REPORTED THAT, "NO HARM TO PATIENT. J [JEJUNOSTOMY] TUBE EXTENSION BROKEN AT MED [MEDICATION] PORT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882877 ↗
• MalfunctionJul 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE "MEDICINE PORT CAP OF THE ENTERAL FEEDING EXTENSION SET WILL OCCASIONALLY COME LOOSE, RESULTING IN THE LOSS OF ENTERAL FEED, AND THE EMPTYING OF GASTRIC CONTENTS. THIS DOES NOT OCCUR WITH THE DESIGN OF THE COMPETITORS PRODUCT THAT WE SWITCHED FROM. THE MIC-KEY EXTENSION SETS HAVE CAPS THAT SCREW CLOSED WITH THREADS, WHEREAS THE MINI ONE CAPS USE FRICTION ALONE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766554 ↗
• MalfunctionOct 6, 2021Crack; Fluid/Blood Leak; Fitting Problem

  PER THE ORIGINAL REPORTER'S DESCRIBED EVENT OR PROBLEM FROM REPORT #: (B)(4), THE FOLLOWING WAS REPORTED: "PROBLEM 1: THE NURSES REPORTED THAT THE NEW ENFIT AMT MINI ONE ENTERAL EXTENSION SETS LEAK OUT THE MEDICATION PORT WHEN THE TUBE FEEDINGS ARE INFUSING. THE NURSES REPORTED THAT THE CAP DOES NOT FIT SECURELY AND WHEN THE CONTINUOUS FEEDINGS ARE INFUSING THE MEDICATION PORT CAP POPS OFF. PROBLEM 2: THE OUTSIDE WHITE PORTS CRACK OFTEN REQUIRING TUBING CHANGES. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: PROVIDE TUBING FOR CONTINUOUS ENTERAL FEEDING."

  Patient problems: Insufficient Information

  MAUDE report 12586452 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component

  THIS REPORT IS IN RESPONSE TO INITIAL REPORT #MW5100424, WHICH PROVIDED THAT THE MINI ONE 24" RIGHT ANGLE FEEDING SET WITH Y-PORT Y PORT SEPARATED FROM TUBING WHEN DISCONNECTING SYRINGE FROM Y PORT. NO OBVIOUS CUTS OR DAMAGE SEEN TO NAKED EYE. PATIENT NOT HARMED. GASTRIC CONTENTS EMPTIED INTO BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890598 ↗

Other Applied Medical Technology, Inc. products

• NutraGlide Nasal Feeding Tube8 models · 3 reports · 9 recalls
• AMT Mini Extension Set3 models · 6 reports · 1 recall
• AMT Initial Placement Dilator Set2 models · 3 reports · 1 recall
• AMT Bridle4 models · 2 reports · 1 recall
• Mini ONE Balloon Button15 models · 33 reports