Bivona 750190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15021312006438), received between Feb 8, 2018 and Apr 21, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Contamination; Device Dislodged or Dislocated; Material Split, Cut or Torn; Contamination; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PILOT LINE SPRING VALVE WAS PUSHED INTO THE VALVE, AND IT WAS DIFFICULT TO ACCESS FOR INFLATION/DEFLATION/CUFF PRESSURE CHECKS. THE TRACH WAS CHANGED OUT FOR NEW ONE. THERE WAS A PATIENT INVOLVEMENT, HOWEVER THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873217 ↗
• MalfunctionMar 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACH TUBE DIDN'T INFLATE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789359 ↗
• MalfunctionNov 14, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT INFLATING ON A SMITHS MEDICAL TRACH TUBE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12808343 ↗
• MalfunctionApr 28, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON A SMITHS MEDICAL TRACH TUBE WOULD ONLY PARTIALLY INFLATE. INSTALLATION FAILURE. THEY HAD TO USE ANOTHER CANULA. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735978 ↗
• MalfunctionJan 29, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON A SMITHS MEDICAL TRACH TUBE WOULD ONLY PARTIALLY INFLATE. INSTALLATION FAILURE. THEY HAD TO USE ANOTHER CANULA. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11249131 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED THAT A PATIENT WITH A SMITHS MEDICAL BIVONA® ADULT AIRE-CUF® TRACHEOSTOMY TUBE WAS NOT RECEIVING AIR. SUBSEQUENTLY, THE TUBE WAS CHANGED OUT AND THE PATIENT WAS ABLE TO BREATHE NORMALLY. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Airway Obstruction

  MAUDE report 7251401 ↗

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.