Mini ONE® Balloon Button M1-5-1412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842071100148), received between Feb 22, 2017 and Nov 25, 2020 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2020No Apparent Adverse Event; No Apparent Adverse Event

  PER ORIGINAL REPORT #: (B)(4), "DESCRIBE THE EVENT OR PROBLEM: G-TUBE LEAKING, REMOVED AND FLUSHED BALLOON NOTED TO BE LEAKING. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)."

  Patient problems: Insufficient Information

  MAUDE report 10900187 ↗
• InjuryFeb 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY USER FACILITY: PATIENT FOR SECOND OPERATING ROOM RELATED TO A GT COMPLICATION ORIGINALLY INSERTED APPROXIMATELY THREE DAYS PREVIOUSLY. PT TO OPERATING ROOM FOR LAP NISSEN/GT (14FR 1.2CM AMT BUTTON). THREE DAYS LATER IN THE MORNING, FEEDINGS WERE INCREASED. THAT SAME DAY IN THE AFTERNOON, STAY SUTURES REMOVED BY SURGICAL FELLOW. RN FOUND GT (GASTRIC TUBE) ELEVATED AWAY FROM SKIN. UNCLEAR TO RN IF BALLOON WAS FILLED WITH WATER. PT MADE NPO. SURGERY CALLED NOTIFIED. DYE STUDY ORDERED TO ASSESS FOR PROPER PLACEMENT. READING BY RADIOLOGIST STATED THAT GT IN PLACE WITH NO LEAK. CONFIRMED. THAT SAME DAY IN THE EVENING, FEEDING WAS RESTARTED. THE FOLLOWING MORNING, GT LEAKING. FORMULA COLORED FLUID ACCUMULATED UNDER DRESSING. NNP NOTIFIED, PT MADE NPO. SURGERY TEAM CALLED AND REMOVED GT AND PLACED 10 FR FOLEY. P ADMINISTERED ISO DYE BY MD AND X-RAYS OBTAINED. PATIENT SCHEDULED FOR OPERATING ROOM. PATIENT WAS TAKEN TO OPERATING ROOM THAT DAY: DISLODGED GASTROSTOMY TUBE WITH PERITONITIS, DIAGNOSTIC LAPAROSCOPY, LAPAROTOMY, STAMM GASTROSTOMY.

  Patient problems: Patient Problem/Medical Problem; Peritonitis

  MAUDE report 6350711 ↗