Bivona XT25BS55NGF207NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887709149127), received between Apr 1, 2025 and Jun 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K923878); they may or may not involve this specific model.

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.

• MalfunctionJun 19, 2025Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE THE TRACH CARE WAS BEING PERFORMED, A TEAR IN FLANGE WAS FOUND. TEAR IN TRACH FOUND. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289608 ↗
• MalfunctionApr 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT SEEM TO INFLATE AND ONLY THE PILOT BALLOON WAS INFLATING. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED. THE EVENT OCCURRED AFTER INITIAL STERILIZATION. THEY ATTEMPTED TO CHECK THE CUFF WITH 5, 10 & 15 CC OF WATER MULTIPLE TIMES BUT STILL CUFF DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746955 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.