Smiths Medical has also notified the FDA regarding the “potential issues” with some of its Bivona tracheostomy tubes due to manufacturing defects. Image credit: Emine Kamaci / Shutterstock.

A week after recalling its infusion pumps, Smiths Medical, part of ICU Medical, has sent out an urgent medical device notification regarding “potential issues” with some of its Bivona tracheostomy tubes.

The issue is due to a manufacturing defect that may result in a torn or broken flange, which could lead to displacement or decannulation of the tracheostomy tube. This can result in an “inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event”.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

A tracheostomy is a surgical procedure where an opening is created in the trachea (windpipe) and a tracheostomy tube is inserted. This is done to provide an air passage to help a patient breathe when the usual route for breathing is somehow blocked or reduced. The procedure is often done when patients are put on ventilators.

The letter was sent on 29 May 2024 to all customers who received any affected product. Smiths Medical stated that it will provide customers with a replacement and/or credit.

The letter went on to outline the required customer actions. Smiths Medical noted that customers should check their inventory against the affected catalogue numbers list provided by the company. The affected products are not used and can be either discarded or quarantined until disposal. Smiths Medical has also notified the US Food and Drug Administration (FDA) of the issue.

See Also:

GlobalData expects the market for tracheostomy tubes to steadily increase both in the total value and volume from 2024 through to 2033. The market is expected to be worth approximately $182.2m in 2024, to over $206.5m by 2033.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Smiths Medical has had two device recalls this year. In April, the company issued a Class I recall of its transport ventilators. The recall followed 177 reports of device issues and eight injuries related to the Pneupac Parapac Plus ventilator kits.

In August, Smiths Medical issued a device correction for its CADD-Solis and CADD-Solis VIP infusion pumps after software issues. The recall affected devices with older software versions and can result in multiple operational failures, including malfunctioning alarms and detection systems.