Bivona 67NFPS25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688518774), received between Sep 13, 2022 and Sep 20, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 29, 2024Class IOpen, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2609-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING HOSPITAL PRE-TEST OF THE TRACHEOSTOMY TUBE, THE BALLOON WOULD NOT INFLATE CORRECTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456286 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHS FOUND IN INVENTORY ARE NOT INFLATING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410367 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHS FOUND IN INVENTORY ARE NOT INFLATING. NO PATENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410363 ↗

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.