Mini ONE® Balloon Button SM1-5-1255Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842071119904), received between Feb 9, 2022 and Mar 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 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.

• MalfunctionMar 15, 2022Material Rupture; Device Dislodged or Dislocated

  PER THE ORIGINAL REPORT RECEIVED BY AMT IN UF REPORT #: (B)(4), "RN ADMINISTERED MEDICATION AND STERILE WATER FLUSH THROUGH GTUBE MIC-KEY EXTENSION WITHOUT A PROBLEM. RN TURNED TO GET FEEDING SYRINGE AND WHEN SHE TURNED BACK TOWARD THE PATIENT SHE SAW THAT THE WHOLE GTUBE BUTTON AND EXTENSION WAS OUT OF THE PATIENT ON THE BED. THE BALLOON BUTTON APPEARED TO BE COMPLETELY DEFLATED. RN IMMEDIATELY PUT A RED RUBBER CATHETER IN THE HOLE TO MAINTAIN PATENCY. A REPLACEMENT BALLOON BUTTON WAS INSERTED EASILY INTO PLACE. AN ABDOMINAL XRAY WAS DONE TO CONFIRM PLACEMENT PRIOR TO FEEDS BEING RESUMED. 2 RNS WERE PRESENT AND EXAMINED THE OLD BALLOON BUTTON. THE BALLOON DID NOT APPEAR TO BE HOLDING THE CORRECT SHAPE/WAS EASILY DISFORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13775606 ↗
• MalfunctionFeb 9, 2022Material Rupture; Device Dislodged or Dislocated

  RN ADMINISTERED MEDICATION AND STERILE WATER FLUSH THROUGH GTUBE MIC-KEY EXTENSION WITHOUT A PROBLEM. RN TURNED TO GET FEEDING SYRINGE AND WHEN SHE TURNED BACK TOWARD THE PATIENT SAW THAT THE WHOLE GTUBE BUTTON AND EXTENSION WAS OUT OF THE PATIENT ON THE BED. THE BALLOON BUTTON APPEARED TO BE COMPLETELY DEFLATED. RN IMMEDIATELY PUT A RED RUBBER CATHETER IN THE HOLE TO MAINTAIN PATENCY. A REPLACEMENT BALLOON BUTTON WAS INSERTED EASILY INTO PLACE. AN ABDOMINAL XRAY WAS DONE TO CONFIRM PLACEMENT PRIOR TO FEEDS BEING RESUMED. 2 RNS WERE PRESENT AND EXAMINED THE OLD BALLOON BUTTON. THE BALLOON DID NOT APPEAR TO BE HOLDING THE CORRECT SHAPE/WAS EASILY DISFORMED.

  Patient problems: Insufficient Information

  MAUDE report 13497180 ↗