Mini ONE® Balloon Button M1-5-1410-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842071113940), received between Jan 11, 2022 and Dec 19, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  PER THE ORIGINAL REPORTER, THE BALLOON DEFLATED AFTER FIVE (5) DAYS OF USE AND THE PATIENT PRESENTED WITH FEVERS AND PERITONITIS, REQUIRING AN EMERGENCY LAPAROTOMY TO REPAIR THE STOMACH AND REPLACE THE GASTRIC TUBE. THE PATIENT WAS THEN TREATED WITH 7 DAYS OF ANTIBIOTICS AND IS NOW TOLERATING TUBE FEEDS.

  Patient problems: Fever; Peritonitis

  MAUDE report 18358613 ↗
• MalfunctionNov 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF/IMPORTER REPORT #: (B)(4), "GASTROSTOMY TUBE BALLOON BROKE DURING INFLATION, TROCAR. PORTION OF TROCAR BROKE OFF DURING USE. PATIENT ADMITTED FOR LAPAROSCOPIC G TUBE. WHEN USING ELBOW ITEMS, AN ORANGE PIECE BROKE OFF TROCAR. ITEM RETRIEVED AND THE BUTTON ON THE G-TUBE BROKE OFF. ITEM RETRIEVED. NO HARM TO PATIENT. ITEMS GIVEN TO PURCHASING MANAGER [REDACTED NAME] FOR REVIEW WITH COMPANY. 5MM TROCAR REF# MS100705, LOT #P3E0261. GASTRIC BUTTON G TUBE REF# M1-5-1410-I, LOT #221210-042.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065491 ↗
• MalfunctionMar 1, 2022Fracture; Leak/Splash

  PER THE ORIGINAL REPORTER IN UF REPORT #: (B)(4): "G-TUBE WAS PLACED AND FOUND TO BE LEAKING AROUND THE BASE WHEN FEEDS WERE ADMINISTERED FOR THE FIRST TIME. G-TUBE HAD TO BE REPLACED. UPON VISUAL EXAMINATION, THERE WAS WHAT APPEARS TO BE A FRACTURE IN THE RUBBER NEAR THE BASE OF THE TUBE. IT IS UNLIKELY THE FRACTURE OCCURRED DURING PLACEMENT AND SEEMS TO BE A MANUFACTURING DEFECT. IN THE PHOTOS, A PIECE OF ELECTRONIC SOLDER WAS PLACED THROUGH THE CRACK TO MAKE IT MORE VISIBLE. WITHOUT THE WIRE, THE CRACK WAS EXTREMELY DIFFICULT TO SEE. THE BALLOON PORTION IS INTACT AND FUNCTIONS PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637474 ↗
• MalfunctionJan 11, 2022Device Dislodged or Dislocated; Gas/Air Leak

  BASED ON THE ORIGINAL REPORTER'S PROVIDED REPORT # (B)(4), "THE INTERNAL RETENTION BALLOON OF THE 14FR X 1.0CM MINIONE® BALLOON BUTTON LOW PROFILE FEEDING DEVICE LEAKED CAUSING THE GASTROSTOMY TUBE TO BE DISLODGED FROM THE PATIENT. PATIENT'S MOTHER REPORTED THIS AS THE SECOND TIME THIS HAS HAPPENED, A SIMILAR SITUATION OCCURRED TWO WEEKS PRIOR WHERE THE TUBE CAME OUT AND THE BALLOON WAS NOT INTACT. WHEN TRYING TO INFLATE THE TUBE THERE WAS OBVIOUS LEAKAGE NOTED (LOT 210715-116, EXPIRATION DATE 2024-06-01, REF # M1-5-1410-I)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232815 ↗