AMT MiniONE Extension Set 8-1255-ISOSAFRecalls & reported problems
Applied Medical Technology, Inc. · 12" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Box 10), MDR · Class 2
Data updated Oct 18, 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 00842071132446), received between Mar 26, 2025 and Mar 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K110804, K123716, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Fracture; Fracture
PER THE ORIGINAL REPORTER IN UF#: (B)(4), IT WAS REPORTED THAT, "AT THE HUB WHERE YOU SCREW SYRINGES INTO FOR A G-TUBE AND MIDDLE PIECE HAD BROKEN OFF AND WAS MISSING NOT ALLOWING THE COVER TO SECURE TO TUBE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21699693 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110804, K123716, 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
- Z-1497-2016 · Jan 26, 2016 · TerminatedAMT 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
Other Tubes, Gastrointestinal (And Accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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