Mini ONE® Balloon Button M1-5-1208-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842071113810), received between Nov 22, 2023 and Oct 15, 2025 — classified as 4 malfunctions.

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

• MalfunctionOct 15, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDSUN REPORT #:(B)(4), IT WAS REPORTED THAT, "DURING SHIFT REPORT, DAY RN WAS TOLD THAT THE G TUBE WAS "LOOSE" AND COMMENTED ON BY PT'S MOTHER AND NURSE. PT'S SKIN SURROUNDING THE G TUBE IS ERYTHEMATOUS, EDEMATOUS, AND PAINFUL TO THE TOUCH. AT APPROX. 1300 BEDSIDE RN PERFORMED ROUTINE G [GASTRIC] TUBE CARES CONSISTING OF CLEANSING WITH NS AND GAUZE, APPLYING MANUKA HONEY, AND REAPPLYING TAPE-PER WOUND ORDER (NO TURNING). RN NOTED HOW LOOSE THE G TUBE WAS BUT SAFELY PERFORMED CARES. AFTERWARDS, AT APPROX 1315, RN ATTEMPTED TO OBTAIN A GIRTH, AT WHICH TIME THE PT BORE DOWN IN PAIN AND RN WITNESSED THE G TUBE BUTTON DISLODGE AND IMMEDIATELY CALLED THE NP [NURSE PRACTITIONER] TO BEDSIDE. UPON INVESTIGATING, IT WAS NOTED THAT THE G TUBE BALLOON HAD A PINHOLE LEAK IN IT AND WAS DEFLATED, VERIFIED BY THE OBSERVATION OF A LEAK WHEN INSTILLING NEW WATER INTO THE BALLOON".

  Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 23282564 ↗
• MalfunctionNov 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF #: (B)(4), IT WAS REPORTED THAT THE, "G-TUBE WAS DISCOVERED TO HAVE DISLODGED. UPON INVESTIGATION BY MEDICAL PERSONNEL, THE BALLOON WAS FOUND TO HAVE A HOLE AND HAD BECOME DEFLATED. THIS MADE IT SO THAT IT SLIPPED OUT BY ITSELF. THE G-TUBE WAS STILL CONSIDERED CRITICAL AND PATIENT HAD TO HAVE NEW G-TUBE PLACED BY SURGEON AT THE BEDSIDE. PATIENT WAS UNABLE TO GET NEEDED MEDS AND FOOD DURING THE TIME THAT THE G-TUBE WASN'T WORKING. IT WAS DISCOVERED WHEN MEDS AND FORMULA WERE FOUND TO HAVE MADE SWADDLE BLANKET WET".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631190 ↗
• MalfunctionSep 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A, "12 FR GT BALLOON DAMAGED AND LEAKING. SURGICAL TEAM TO BEDSIDE AND REPLACED GASTRONOMY TUBE (GT). FOLLOW-UP IMAGING REQUIRING TRANSPORTING PATIENT TO X-RAY FOR IMAGING STUDIES NEEDED. G-T SAVED IN BIOHAZARD BAG AND PLACED IN DEFECTIVE PRODUCT BIN. THIS IS THE SECOND INCIDENCE OF SOMETHING LIKE THIS HAPPENING FOR THIS PATIENT'S GT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135960 ↗
• MalfunctionNov 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL MEDWATCH REPORT #: (B)(4). IT WAS REPORTED THAT "UPON CHECKING PLACEMENT OF GASTROSTOMY FEEDING TUBE, MILK LEAKAGE WAS FOUND ON PATIENT'S CLOTHING & BLANKET. BALLOON WAS CHECKED AND FOUND TO BE RUPTURED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194758 ↗