AMT Mini ONE® Extension Set E8-1255-ISOSAFRecalls & reported problems
Applied Medical Technology, Inc. · 12" Mini ONE® RIGHT ANGLE Feeding Set with Dual ENFit ® Y-PORT (Pouched) · Class 2
All models of AMT Mini ONE Extension Set (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071107697), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
1 other recall cover devices cleared under the same FDA submission (K142989, K971757); 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
Device problems
- Crack1
- Fitting Problem1
- Fluid/Blood Leak1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142989, K971757. One submission often covers many models, so check the product and lot details in each record.
- Z-0819-2025 · Nov 26, 2024 · CompletedAMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Other Gastrointestinal Tubes With Enteral Specific Connectors devices
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Standard PEG Kit M00509050Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
- Salem Sump 8888268060ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall0 reports
- Salem Sump 7771810ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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