Mini ONE® Balloon Button M1-5-1412-IRecalls & reported problems
Applied Medical Technology, Inc. · 14FR x 1.2cm Mini ONE® Balloon Button (Boxed Kit - ISOSAF) 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
- 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 00842071113957), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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 Separation1
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 17, 2025Material Separation; Material Separation
PER THE ORIGINAL REPORTER IN UF #:(B)(4), IT WAS REPORTED THAT THE, "REGISTERED NURSE (RN) NOTED THAT MINIONE BALLOON BUTTON GASTRONOMY TUBE (GT) LIFTING SLIGHTLY TO ONE SIDE. TUBING TAPED TO PREVENT ANY TUGGING. SITE FLUSHED, NO LEAKING NOTED AT GT STOMA SITE. MEDICATIONS ADMINISTERED AT [TIME REDACTED]. RN FLUSHED AND NOTED NO LEAKING AT STOMA SITE. PULLED BACK FROM BALLOON INFLATION PORT AND NOTED 1ML GASTRIC CONTENT. GT BALLOON PORT INFLATED AND UNABLE TO PULL BACK POST INFLATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621385 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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