Bivona 67PFP50Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688518514), received between Jun 15, 2022 and Jul 8, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (2 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-2611-2024 · 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.

• MalfunctionJul 8, 2026Incomplete or Inadequate Connection

  IT WAS STATED THAT A PEDIATRIC TRACHEOSTOMY TUBE HAD AN ISSUE WITH TWO TUBES SPLITTING WHILE IN USE WITH ONE OF THE PEDIATRIC PATIENTS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THIS EVENT WOULD CAUSE IN ADEQUATE VENTILATION TO THE PATIENT WHEN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753064 ↗
• MalfunctionJul 8, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753056 ↗
• MalfunctionJun 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF INFLATED ASYMMETRICALLY DURING TESTING, PRIOR TO USE. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14699448 ↗

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.