Bivona 67PFSS25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688518668), received between Sep 12, 2022 and Sep 26, 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 16, 2026.

Recalls naming this device

1. May 29, 2024Open, 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-2614-2024 · 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 26, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACHEOSTOMY PATIENT BEING MANAGED FOR A POSTNATALLY DIAGNOSED POLYMALFORMATIVE SYNDROME AND WHEN CHANGING THE TRACHEOSTOMY CANNULA, DURING THE CUFF INFLATION TEST, THE NURSE REALIZED THAT THE CUFF DIDN'T INFLATE DESPITE SEVERAL ATTEMPTS TO INFLATE THE CUFF. IT WAS REPORTED THAT THERE WAS NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487781 ↗
• MalfunctionSep 26, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACHEOSTOMY PATIENT BEING MANAGED FOR A POSTNATALLY DIAGNOSED POLYMALFORMATIVE SYNDROME AND WHEN CHANGING THE TRACHEOSTOMY CANNULA, DURING THE CUFF INFLATION TEST, THE NURSE REALIZED THAT THE CUFF DIDN'T INFLATE DESPITE SEVERAL ATTEMPTS TO INFLATE THE CUFF. IT WAS REPORTED THAT THERE WAS NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486389 ↗
• MalfunctionSep 12, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN 8-MONTH-OLD INFANT HOSPITALIZED FOR A POSTNATAL DIAGNOSIS OF POLY MALFORMATIVE SYNDROME. WHEN CHANGING THE TRACHEOSTOMY CANNULA, THE HEALTH PROFESSIONAL NOTICED THAT DROPS OF EPPI WERE COMING OUT OF THE CUFF WHEN TESTING THE CUFF WITH 2ML OF EPPI. THE CUFF WAS NOT INFLATED PROPERLY AND THE CANNULA WAS NOT PLACED. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403240 ↗

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.