MiniONE Balloon Button M1-5-1210-IRecalls & reported problems
Applied Medical Technology, Inc. · 12FR x 1.0cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR · Class 2 · Implant
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 00842071140359), received between Dec 15, 2025 and Dec 15, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event2
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.
MalfunctionDec 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
PER THE ORIGINAL REPORTER IN MEDSUN REPORT #: (B)(4), IT WAS REPORTED, "PATIENT MOTHER WAS DOING G TUBE CARES ON THE PATIENT AND ASKED IF THE G TUBE LOOKED LIKE IT WAS COMING OUT. UPON LOOKING CLOSER, THE G TUBE LOOKED LIKE IT WAS SITTING FARTHER OUT THAN USUAL. I HAD THE NP [NURSE PRACTITIONER] COME AND LOOK AT IT AND SHE SAID IT WAS OK IF I PLACED A NEW ONE. AFTER I REPLACED THE G TUBE WITH A NEW WORKING G TUBE, I CHECKED THE BALLOON ON THE OLD ONE. WHEN I PUT WATER INTO THE BALLOON, THERE WAS A HUGE HOLE IN THE BALLOON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802237 ↗MalfunctionDec 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
PER THE ORIGINAL REPORTER IN MEDSUN REPORT #: (B)(4), IT WAS REPORTED THAT THE "RN CARING FOR PATIENT REPORTED THAT THE GT [GASTRIC TUBE] WAS LEAKING AND THEN FELL OUT, SHOWING THAT THE BALLOON WAS PUNCTURED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23801862 ↗
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- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- 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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