Mini ONE® Balloon Button M1-5-1210Recalls & reported problems
Applied Medical Technology, Inc. · 12FR x 1.0cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device · Class 2 · Implant
All models of Mini ONE Balloon Button (15)
Data updated Oct 18, 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 00842071100018), received between Feb 12, 2020 and Feb 20, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
- Material Split, Cut or Torn1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2024No Apparent Adverse Event; No Apparent Adverse Event
PER THE ORIGINAL REPORTER IN UF #: (B)(4), IT WAS REPORTED THAT "DURING NURSING CARE, THE INFANT'S G-TUBE BUTTON FELL OUT. RN (REGISTERED NURSE) NOTED THE BALLOON WAS DEFLATED. SURGERY NP (NURSE PRACTITIONER) ASSESSED G-TUBE NOTING A SMALL HOLE IN THE BALLOON. BALLOON REMAINS DEFLATED SECURING G-TUBE IN PLACE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743352 ↗MalfunctionFeb 12, 2020Material Puncture/Hole; Material Split, Cut or Torn
GTUBE NOTED TO BE OUT DURING CARES. OLD GTUBE ASSESSED AND WAS FOUND TO BE ALL INTACT EXCEPT FOR A HOLE ON THE BALLOON. SLIGHT TEAR NOTED TO THE TOP OF THE BALLOON. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9707153 ↗
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- 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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