Bivona 67SP025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312000665), received between Nov 13, 2021 and Sep 14, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

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. How this data works · Data updated Oct 13, 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 · 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 14, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT DURING A ROUTINE TRACH TUBE CHANGE, THE DEVICE CUFF WOULD NOT FILL FULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418147 ↗
• InjuryNov 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT STARTED TO DESATURATE DURING AN EMERGENCY PROCEDURE. A TRACH HAD TO BE USED BUT THE TRACH WAS NOT INFLATING. SEEN WITH TWO TRACKS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12808237 ↗
• InjuryNov 13, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PATIENT STARTED TO DESATURATE DURING AN EMERGENCY PROCEDURE. A TRACH HAD TO BE USED BUT THE TRACH WAS NOT INFLATING. SEEN WITH TWO TRACKS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12808229 ↗

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.