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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842071100001), received between Feb 12, 2020 and Nov 4, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN FDA REPORT #: MW5112222, IT WAS INDICATED THAT THE DEVICE BROKE. FURTHER FOLLOW-UP WITH THE REPORTER DETERMINED THAT THE DEVICE WAS PLACED DURING A PROCEDURE AND BROKE DURING A SURGERY, SO A NEW DEVICE WAS REPLACED AND WORK APPROPRIATELY. IT WAS ALSO REPORTED THAT NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724724 ↗
• MalfunctionMay 20, 2020Device Dislodged or Dislocated

  PATIENT GASTRIC TUBE (GT) WAS NOTED OUT AND LAYING IN BED AFTER WORKING WITH PT DURING FIRST CARE. PT WAS VOCAL ABOUT A PREVIOUS HISTORY OF THE GT BECOMING DISLODGED DURING MULTIPLE/DIFFERENT TIMES AND STATED WOULD BE EXTRA CAREFUL OF THIS DURING THERAPY. ALSO STATED IN REPORT GT BECAME DISLODGED MULTIPLE TIMES OVER 2-WEEK PERIOD. BALLOON ON GT LOOKED MALFUNCTIONED. NO BLEEDING. GT CALLED GT MINI ONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE. 12 FRENCH 0.8 CM LOT NUMBER 180920-366. EXPIRATION 07/01/2021. SURGICAL FELLOW NOTIFIED IMMEDIATELY BY PHONE AND CAME TO REINSERT A BRAND-NEW GT. I EXPLAINED WHAT HAPPENED AND THAT SURGICAL FELLOW CAME TO BEDSIDE AND UP SIZED HER GT TO A 12 FRENCH 1.2 CM GT WITHOUT INCIDENT. NO BLEEDING TO SITE. RESIDENT TEAMMATE NOTIFIED AND EXPRESSED SHE WOULD RELAY INFO TO NURSE PRACTITIONER. DISCUSSED WITH ORANGE TEAM INCIDENT OF GT BECOMING DISLODGED DURING ROUNDS IN FRONT OF SURGICAL FELLOW. MANUFACTURER RESPONSE FOR BUTTON G TUBE FEEDING DEVICE, MINI ONE® BALLOON BUTTON (PER SITE REPORTER). MANUFACTURER HAS BEEN VERY HELPFUL AND IS ARRANGING FOR RETURN AND EVALUATION OF ALL AVAILABLE DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10074348 ↗
• MalfunctionMay 19, 2020Inflation Problem; Device Fell

  PATIENT'S 12FR AMT G-TUBE FELL OUT DURING HANDS ON CARE. BALLOON ON G-TUBE THAT FELL OUT WAS DEFLATED. BALLOON WAS TESTED AFTER IT FELL OUT AND WAS LEAKING. MANUFACTURER RESPONSE FOR LOW PROFILE FEEDING DEVICE, MINI ONE BALLOON BUTTON (PER SITE REPORTER) MANUFACTURER IS SENDING LABEL FOR RETURN TO CONDUCT AN INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10069675 ↗
• MalfunctionFeb 14, 2020Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  MINI ONE BALLOON BUTTON WAS LEAKING IN PT, IT WAS REMOVED FROM THE PT AND FOUND TO HAVE A TEAR AND NOT INFLATING. STAFF OBTAINED A NEW MINI ONE BALLOON BUTTON AND TESTED IT AT BEDSIDE BEFORE INSERTING IT IN THE PT. THE NEW BALLOON WAS FOUND TO HAVE A TEAR AND WOULD NOT INFLATE. THIS REPORT IS FOR THE NEW BALLOON THAT WAS TESTED AT BEDSIDE AND WAS DEFECTIVE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720566 ↗
• MalfunctionFeb 12, 2020Fluid/Blood Leak; Inflation Problem; Tear, Rip or Hole in Device Packaging

  INFANT NOTED TO HAVE REDNESS AROUND GTUBE. WHILE FEEDING WAS RUNNING, NOTED LEAKAGE AROUND THE GTUBE AND IT CAME OUT. WHEN VERIFIED THE BALLOON, NOTED TO HAVE TEAR AND NOT INFLATING. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Skin Irritation

  MAUDE report 9707137 ↗