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

Smiths Medical indicates that their Bivona tracheostomy tubes may not remain in proper position after placement in the trachea, potentially resulting in severe injury or death.

An urgent medical device notification has been issued by Smiths Medical about defects with Bivona tracheostomy tubes, which might tear or break after they are placed in the trachea, potentially leading to tracheostomy displacement or decannulation.

A tracheostomy is a procedure that is done when the trachea, or windpipe, is blocked, and the patient can no longer breathe properly. The trachea is surgically opened, and a tracheostomy tube is inserted into the neck to help the patient breathe. Decannulation is the process involved in removing the tube from the neck.

The U.S. Food and Drug Administration (FDA) posted information about the Bivona tracheostomy tube defects on September 4, warning about the risk of severe problems that occur if the flange tears or breaks, which may lead to a “catastrophic adverse event.”

Smiths Medical first sent a letter to certain medical providers about the problems on May 29, indicating that the manufacturer had already received at least 35 reports of serious injuries and one death.

The warning impacts both Bivona neonatal/pediatric and adult tracheostomy products, including Bivona Aire-Cuf, TTS, Uncuffed and Mid-Range neonatal/pediatric tracheostomy tubes, as well as Bivona Aire-Cuf, TTS, Cuffless FlexTend and TTS FlexTend adult tracheostomy tubes.

As a result of the product defects, Smiths Medical is urging all customers who still have recalled Bivona tracheostomy tubes in their inventory to immediately discard the products or place them in quarantine until they are able to dispose of them properly. Local company representatives are available to offer assistance with replacement products or credits.

A list of the affected product’s serial numbers can be found on the Smiths Medical website.

Customers who want to report adverse events directly to Smiths Medical can call the company’s global complaint management service at 1-866-216-8806, or they can email the company at globalcomplaints@icumed.com.

For questions about replacements or credits, the company can be reached at either 1-800-258-5361 or customerservice@icumed.com. Smiths Medical became a subsidiary of ICU Medical in January 2022.

This warning from Smiths Medical is separate from two device recalls the company already issued this year. In April, Smiths Medical recalled its Pneupac Parapac Plus ventilator kits, following reports of 177 device issues and eight injuries. The company also issued a device correction for the CADD-Solis and CADD-Solis VIP infusion pumps in August.

Customers who have seen or experienced any adverse effects from Smiths Medical’s Bivona tracheostomy tubes are encouraged to contact the FDA either at www.fda.gov/medwatch or at 1-888-INFO-FDA.