Mini ONE® Balloon Button M1-5-1212Recalls & reported problems
Applied Medical Technology, Inc. · 12FR x 1.2cm 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
- 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 00842071100025), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Leak/Splash1
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.
MalfunctionApr 20, 2021Inflation Problem; Leak/Splash
PER THE INITIAL REPORTER'S ORIGINAL REPORT IN REPORT #: (B)(4), "G TUBE DISLODGED/REMOVED. INFANT WAS TRANSFERRED WITH A GASTROSTOMY TUBE (GT). BALLOON WAS FOUND TO HAVE A LEAK. 10FR SUCTION TUBE USED TO MAINTAIN PATENCY. BALLOON ON DEVICE FAILED. ON INSPECTION DEVICE BALLOON WILL NOT INFLATE A SMALL AMOUNT BUT BEYOND 0.5ML OF AIR EVERYTHING JUST LEAKS OUT. THIS DEVICE WAS PLACED BY AN OUTSIDE FACILITY SO NO LOT NUMBER INFORMATION IS AVAILABLE. MANUFACTURER HAS BEEN CONTACTED BY EMAIL. THERE WAS NO DETECTABLE HARM."
Patient problems: Insufficient Information
MAUDE report 11697365 ↗
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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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