Mini ONE® Balloon Button M1-5-1417-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842071113971), received between Mar 18, 2022 and Sep 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Contamination; Contamination

  PER THE ORIGINAL REPORTER IN UF/IMPORTER REPORT #: (B)(4), " A STERILE PACKAGE WITH A 14FR X 1.7CM MINI ONE(R) BALLOON BUTTON (BOXED KIT - ISOSAF) LOW PROFILE FEEDING DEVICE THAT WAS UNOPENED WAS FOUND TO HAVE A HAIR THAT WAS WRAPPED AROUND THE BUTTON PORTION IN THE KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501344 ↗
• MalfunctionMar 18, 2022Material Rupture; Device Dislodged or Dislocated

  PER THE ORIGINAL EVENT REPORTED IN UF REPORT #: (B)(4), "PATIENT HAD A CECOSTOMY TUBE PLACED 8 DAYS PRIOR TO THE EVENT. THE DEVICE PLACED WAS AN AMT 14 FR 1.7CM LENGTH BUTTON. TWO DAYS LATER, THE TUBE WAS FOUND DISLODGED FROM PATIENT. THE BALLOON THAT WAS HOLDING THE TUBE IN PLACE WAS RUPTURED. THE PEDIATRIC SURGERY RESIDENT REPLACED IT AT BEDSIDE WITH ANOTHER TUBE AS A PLACEHOLDER. THE PATIENT DID REQUIRE A NEW TUBE TO BE PLACED UNDER FLUOROSCOPY WITH INTERVENTIONAL RADIOLOGY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13807424 ↗