Mini ONE® Balloon Button M1-5-1210-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842071113827), received between Oct 12, 2023 and Jun 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn

  PER THE ORIGINAL REPORTER IN MDR REPORT #: MW5170433, IT WAS REPORTED THAT,"ON (B)(6) 2025, THE INTERNAL BALLOON IN OUR DAUGHTER'S G TUBE (GASTROSTOMY TUBE) FAILED CAUSING IT TO BE DISLODGED. THIS REQUIRED US TO INSERT A FOLEY CATHETER AND TRAVEL TO THE EMERGENCY ROOM AT (B)(6) TO HAVE A NEW G TUBE INSERTED AND A FLUOROSCOPY TO CONFIRM PLACEMENT. IN THE TWO WEEKS SINCE SHE HAS HAD HER G TUBE, THIS IS THE SECOND TIME IT HAS FALLEN OUT DUE TO A MANUFACTURING DEFECT CAUSING THE INTERNAL BALLOON TO FAIL. THE FIRST TIME WAS ON (B)(6) 2025 WHILE SHE WAS STILL INPATIENT IN THE NEWBORN CRITICAL CARE CENTER. ON THAT TIME, SHE HAD TO WAIT 10 HOURS BETWEEN FEEDS DUE TO THE WAIT TO GET THE FLUOROSCOPY STUDY DONE TO CONFIRM PLACEMENT BEFORE SHE COULD BE FED AGAIN. AS A YOUNG INFANT, IT WAS VERY DISTRESSING FOR HER TO MISS MULTIPLE SCHEDULED FEEDS DUE TO THIS MANUFACTURING ERROR. WE WERE TOLD BY THE PEDIATRIC SURGERY TEAM AT (B)(6) THAT THEY CHECKED THE BALLOON AND THERE WAS A SMALL LEAK WHICH CAUSED IT TO FAIL. THEY SAID THEY HAVE CONTACTED THE MANUFACTURER IN THE PAST AND WERE TOLD THAT SOMETIMES THE LINING OF THE BALLOON IS SHAVED DOWN TOO FAR CAUSING IT TO FAIL PREMATURELY. THIS IS AN UNACCE

  Patient problems: Distress; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204499 ↗
• MalfunctionOct 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORT IN MDR #: MW5145075, "FAILED DEVICE: BUTTON MINIONE G-TUBE BALLOON BURST. PATIENT REQUIRED REPLACEMENT OF THE TUBE WITH WASHOUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928086 ↗