Mini ONE® Balloon Button M1-5-1215Recalls & reported problems
Applied Medical Technology, Inc. · 12FR x 1.5cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device · Class 2 · Implant
All models of Mini ONE Balloon Button (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842071100032), received between Jul 27, 2021 and Jun 25, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Device Dislodged or Dislocated1
- Leak/Splash1
- No Apparent Adverse Event1
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2023No Apparent Adverse Event; No Apparent Adverse Event
PER THE ORIGINAL REPORTER TO UF/IMPORTER REPORT #: (B)(4), IT WAS DOCUMENTED THAT "G-TUBE WAS FOUND TO BE DISLODGED FROM INFANT'S ABDOMEN. UPON INSPECTING THE MINI BUTTON, THE BALLOON WAS DEFLATED. TRIED TO REINFLATE THE BALLOON WITH STERILE WATER AND THE BALLOON WOULDN'T HOLD WATER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196239 ↗MalfunctionMar 27, 2023Device Dislodged or Dislocated; Unintended Deflation
G-TUBE WAS FOUND TO BE DISLODGED FROM INFANT'S ABDOMEN. UPON INSPECTING THE MINI BUTTON, THE BALLOON WAS DEFLATED. TRIED TO REINFLATE THE BALLOON WITH STERILE WATER AND THE BALLOON WOULDN'T HOLD WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16617859 ↗MalfunctionJul 27, 2021Crack; Leak/Splash
PER THE ORIGINAL REPORT IN UF REPORT #: (B)(4): "OPENING COMES APART WHEN OPENING CLAMP UP TO PLACE EXTENSION G-TUBE IN PLACE. LOOKS LIKE IS HAS CRACKED APART AND LEAKING WITH FEEDS AROUND."
Patient problems: Insufficient Information
MAUDE report 12235161 ↗
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- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
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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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