‘Catastrophic’ Risk Linked To Smiths Medical Trach Tubes

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

Recall Road Sign against sky.
• Source: Shutterstock

Some Bivona tracheostomy tubes may tear and become displaced during use resulting in a “catastrophic adverse event,” the company said in an urgent medical correction letter sent to customers.

The problem with the devices, which are used on both adults and pediatric patients, stems from a manufacturing defect.

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