Mini ONE® Balloon Button M1-5-1417Recalls & reported problems
Applied Medical Technology, Inc. · 14FR x 1.7cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842071100162), received between Sep 7, 2023 and Oct 6, 2023 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2023No Apparent Adverse Event; No Apparent Adverse Event
PER THE ORIGINAL REPORTER IN UF/IMPORTER REPORT #: (B)(4), "PATIENT'S MOM NOTICED PATIENT'S BUTTON PEG WAS LOOSE. WHEN SHE CHECKED THE BALLOON, IT WAS BROKEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17887314 ↗MalfunctionSep 7, 2023
PATIENT'S MOM NOTICED PATIENT'S BUTTON PEG WAS LOOSE. WHEN SHE CHECKED THE BALLOON, IT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17698165 ↗
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- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- 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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