Bivona 67SN025Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15021312000238), received between Sep 13, 2022 and Aug 29, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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-2615-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING THE BALLOON WAS NOT INFLATING. THE DEVICE WAS BEING PREPPED FOR A NEWBORN BABY. THE EVENT DID NOT AFFECT PATIENT CARE. NO INJURY OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647612 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING THE BALLOON WAS NOT INFLATING. THE DEVICE WAS BEING PREPPED FOR A NEWBORN BABY. THE EVENT DID NOT AFFECT PATIENT CARE. NO INJURY OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647583 ↗
• MalfunctionAug 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING THE BALLOON WAS NOT INFLATING. THE DEVICE WAS BEING PREPPED FOR A NEWBORN BABY. THE EVENT DID NOT AFFECT PATIENT CARE. NO INJURY OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647582 ↗
• MalfunctionFeb 23, 2023Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432928 ↗
• MalfunctionFeb 23, 2023Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429547 ↗
• MalfunctionSep 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE FOUND IN INVENTORY IS NOT INFLATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410611 ↗
• MalfunctionSep 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE FOUND IN INVENTORY IS NOT INFLATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410463 ↗
• 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 15410422 ↗
• 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 15410418 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.