Bivona 755190Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15021312006490), received between Apr 9, 2021 and Apr 7, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

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.

• MalfunctionApr 7, 2026Break; Disconnection; Gas/Air Leak

  IT WAS STATED THAT THE INFLATION LINE IS BROKEN AND DISCONNECTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800704 ↗
• MalfunctionSep 4, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE CANNULA LOSES PRESSURE FROM 30 TO 10 WITHOUT ANY EXTERNAL INFLUENCE. THE CUFF LOSES PRESSURE. WITHOUT SPECIAL INCIDENTS, THE CUFF LOSES ITS EFFECT. IT HAD TO BE CONSTANTLY RE-BLOCKED. IN ORDER TO SOLVE THE ISSUE, A NEW CANNULA WAS USED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140602 ↗
• MalfunctionSep 13, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CUFF OF THE CANNULA IS DEFORMED. PATIENT HAS IRRITATED SKIN. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LOT NUMBER IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15414246 ↗
• MalfunctionAug 3, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT AIRE-CUFF FAILED WHILE IN USE. NO INFORMATION ON PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12269453 ↗
• InjuryJul 30, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE FAILED DUE TO CUFF LEAKS. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 12255024 ↗
• InjuryJul 30, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE FAILED DUE TO CUFF LEAKS. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 12255021 ↗
• InjuryJul 30, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE FAILED DUE TO CUFF LEAKS. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 12254997 ↗
• InjuryJul 30, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE FAILED DUE TO CUFF LEAKS. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 12253119 ↗
• InjuryApr 9, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE: BIVONA TUBES ADULT AIRE-CUFF WAS LEAKING. THE REPORT INDICATED ONGOING ISSUES WITH CUFF LEAKING WITH MULTIPLE FACTORS AND NOT EXCLUSIVE TO THE FAULT OF TUB. THE CUFF WAS REPORTED TO BE INSPECTED AND CHECKED PRIOR TO INSERTION. MEDICAL INTERVENTION OF A TRACHEOSTOMY CHANGE OUT WAS DONE.

  Patient problems: Airway Obstruction

  MAUDE report 11645629 ↗

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.