Skip to content

Mini ONE® Balloon Button M1-5-1415Recalls & reported problems

Applied Medical Technology, Inc. · 14FR x 1.5cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071100155), received between Jun 15, 2023 and Jun 15, 2023 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

    PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: (B)(4), IT WAS REPORTED THAT "DURING CHANGING OF TUBING EXTENSION SET, THE TUBE CAME OUT AND THE BALLOON WAS NOTED TO BE COMPLETELY DEFLATED. UPON INSTILLING WATER IN BALLOON, THERE WAS A LEAK FROM THE BALLOON IDENTIFIED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17139462 ↗

Other Tubes, Gastrointestinal (And Accessories) devices

All Tubes, Gastrointestinal (And Accessories) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.