MiniONE Balloon Button M1-5-1215-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071140397), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #S: MW182620, MW182621, MW182622, AND MW182623, IT WAS REPORTED THAT, "MY 2.5YO SON'S GTUBE BUTTON (MINIONE REF M1-1215-I FROM APPLIED MEDICAL TECHNOLOGY INC.) HAS BROKEN AND CEASED WORKING ON FOUR OCCASIONS IN THE PAST TWO WEEKS DESPITE NORMAL USE. WE HAVE DEPLETED OUR SUPPLIES REPLACING THESE BUTTONS, WHICH ARE LASTING ABOUT 72 HOURS ON AVERAGE BEFORE BREAKING. THE SAME PATTERN REPEATS: THE INNER RING CRACKS AND THEN PREVENTS THE EXTENSION CONNECTOR FROM LOCKING INTO PLACE SO WE CANNOT DELIVER EITHER HIS FOOD OR MEDICATIONS. MY SON REQUIRES 24HR GTUBE ACCESS TO PREVENT HYPERAMMONEMIA, WHICH MAY CAUSE PERMANENT NEUROLOGICAL DAMAGE, COMA, AND DEATH. THERE IS NO COMMON LOT NUMBER, MANUFACTURING DATE, OR SUPPLIER SOURCE ACROSS ALL FOUR BROKEN BUTTONS, AND OTHER FAMILIES HAVE REPORTED IN MEDICAL FACEBOOK GROUPS THE SAME FAILURE IN OTHER PARTS OF THE COUNTRY, SUGGESTING THERE MIGHT BE A WIDESPREAD MANUFACTURING DEFECT. I HAVE CONTACTED AMT TO REPORT THE ISSUE AND REQUEST REPLACEMENT SUPPLIES, WHICH THEY INDICATED THEY WILL DO AT THE END OF A 2-4 WEEK INVESTIGATION AND TO UTILIZE THE ED FOR RESUPPLY IN THE INTERIM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620898 ↗