3 results

• Smiths Medical Trach Tubes May Disconnect From Pilot Balloon, Leading to Severe Injury or Death

  October 28, 2024

  Darian Hauf

  Defects in certain Smiths Medical tracheostomy tube kits may pose ventilation and aspiration problems, which have already led to at least 12 reported injuries.

• Trach Tube Recall Announced After Second Death Linked to Bivona Aire-Cuf Problems

  September 19, 2024

  Michael Adams

  Smiths Medical has recalled certain Bivona Aire-Cuff tracheostomy tubes, indicating that manufacturing defects may cause the flange to break or tear, posing a risk of serious and life-threatening injuries.

• Bivona Tracheostomy Tube Defects May Cause “Catastrophic” Adverse Events, FDA Warns

  September 9, 2024

  Michael Adams

  Smiths Medical has issued an urgent medical device notification regarding their Bivona tracheostomy tubes not remaining in the proper position, potentially leading to severe injury or death.