Bivona AT26BS40NSA197NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887709186405), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Fluid/Blood Leak; Fracture; Defective Component

  IT WAS REPORTED THAT THE TRACH WAS ONLY USED IN THE PATIENT FOR APPROXIMATELY 6 HOURS BEFORE A LEAK WAS NOTICED. IT WAS TESTED PRIOR TO INSERTION AND APPEARED TO BE FINE. THE CUFF HAD BEEN INFLATED WITH 2.0-3.0CC OF WATER TO ACHIEVE A PROPER SEAL, AND AFTER THE LEAK WAS NOTED, THE TRACH WAS REMOVED AND IT WAS CONFIRMED THAT THE TTS CUFF WAS BROKEN/FAULTY AND LEAKED WATER WHEN INFLATED. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691044 ↗

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.