Bivona 750150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312006391), received between May 26, 2021 and Jan 26, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 18, 2026.

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.

• InjuryJan 26, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF HAS BEEN DEFLATING WHILE IN PATIENT. REMOVED TRACH AND ADDED 10 ML OF AIR AND WITHIN THE HOUR THERE WAS ONLY 7 ML. PATIENT NORMALLY SITS AT 5MLS. IT IS AN ADULT AIR CUFF TRACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358629 ↗
• MalfunctionMay 26, 2021Defective Device; Defective Device

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT AIRE-CUF TRACHS ARE DEFECTIVE. NO ADVERSE PATIENT EVENTS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890455 ↗
• MalfunctionMay 26, 2021Defective Device; Defective Device

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT AIRE-CUFF WERE REPORTED TO BE "DEFECTIVE." NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11889850 ↗

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.