MiniONE Balloon Button M1-5-1410-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071140779), received between Aug 8, 2025 and Aug 8, 2025 — classified as 1 malfunction.

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.

• MalfunctionAug 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF REPORT #: (B)(4), IT WAS REPORTED THAT, "CALLED TO BEDSIDE BY RN BECAUSE SHE NOTED INCREASED SPACE BETWEEN SKIN AND BASE OF G-TUBE, AND EASE OF MOVEMENT WITH DRESSING CARES. CALLED SURGICAL APP [ADVANCED PRACTICE PROVIDER] ON CALL. SHE RECOMMENDED OBTAINING DYE STUDY AND MAKING INFANT NPO IF ANY CONCERNS WITH G-TUBE, SAID SHE WOULD COME UP BUT ALSO THAT SHE WAS MANAGING TRAUMA AND WOULD LIKELY SEE IN AM. WE OBTAINED DYE STUDY, NORMAL WITHIN TRACT. BEDSIDE RN, CHARGE RN, MD AND MYSELF (APP) CHECKED IF THERE WAS ANY FLUID WITHIN G-TUBE BALLOON, MET RESISTANCE AND WERE UNABLE TO PULL ANYTHING OFF BALLOON. CHECKED OR [OPERATING ROOM] REPORT, INITIALLY HAD 4CC OF WATER IN BALLOON. RE-INSTILLED 0.5CC OF WATER BEFORE MEETING RESISTANCE. VERY LIKELY BASED ON EXAM THAT BALLOON HAD BEEN RUPTURED AND THIS IS WHY THERE WAS INCREASED MOVEMENT IN G-TUBE, DESPITE MAINTAINED WITHIN TRACT. I CALLED SURGICAL APP AND MADE AWARE OF FINDINGS REGARDING BALLOON, NORMAL DYE STUDY AND MAKING INFANT NPO [NIL PER OS]. SHE SAID THEY WOULD SEE INFANT IN AM. G-TUBE REPLACED FINALLY ON [DATE REDACTED] AND SURGICAL TEAM NOTED G-TUBE BALLOON HAD BEEN RUPTURED. PER PREVIOUS PATIENTS,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22752517 ↗