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

Following an FDA warning posted earlier this month about a risk of “catastrophic” problems with Bivona Aire-Cuff tracheostomy tubes, the agency now indicates that the manufacturer has issued a recall, and at least two deaths have been linked to manufacturing defects with the trach tubes.

The recalled Bivona trach tubes are designed to provide air to the lungs following a tracheostomy, which is a surgical procedure performed when a patient’s trachea is blocked, and they can no longer breathe properly. The windpipe is opened surgically, and a tube is inserted into the neck to provide a passageway for air.

According to an Urgent Medical Device Notification (PDF) first issued by Smiths Medical on May 29, the securement flange on specific Bivona neonatal/pediatric and adult trach tubes may tear, which could cause the device to move out of position in the trachea. This can lead to tracheostomy displacement or decannulation, which is the process of removing a trach tube.

The FDA first posted information about the trach tube problems on September 4, indicating that the manufacturer was aware of 35 reported incidents, including at least one death.

This week, the agency posted updated information, indicating that the manufacturer has now issued a trach tube recall for two specific Bivona Aire-Cuf products. The FDA categorized the action as a class I medical device recall, which is the most serious type, suggesting that the recalled trach tubes may cause serious injury or death if they are used.

The new statement also now indicates that there have been two deaths linked to a damaged securement flange on the Bivona trach tubes.

Customers Should Immediately Destroy Affected Aire-Cuf Trach Tubes

The flange on a tracheostomy tube, also known as the faceplate, extends out from either side of the tube, helping secure it to the skin of the neck and stabilize its position.

If the Bivona Aire-Cuf trach tube flange breaks or tears, it may move out of place, causing serious adverse health consequences, including a lack of proper ventilation, loss of a protected airway or death.

The trach tube recall impacts the following products:

• Bivona Aire-Cuf, TTS, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tubes
• Bivona Aire-Cuf, TTS, Cuffless FlexTend, TTS FlexTend Adult Tracheostomy Tubes

Medical providers and distributors still in possession of the recalled Bivona Aire-Cuf tracheostomy tubes are being told to immediately stop using and destroy them.

Distributors should share the recall notice with any customers who may have received impacted products. Customers should also share the letter with other potential users, check their inventory for affected products, and immediately destroy the potentially faulty devices in accordance with the facility’s methods for proper disposal. A list of affected lot and serial numbers can be found on the manufacturer’s website.

Smiths Medical customer response forms should be completed and returned to smithsmedical3513@sedgwick.com within 10 days of receipt. The manufacturer will provide information about replacement products or credits.

The company’s global complaint management department can be reached at 1-866-216-8806 or via email at globalcomplaints@icumed.com. Customers can also contact Smiths Medical customer service at customerservice@icumed.com or 1-800-258-5361. Smiths Medical was purchased by ICU medical in January 2022.

The current Smiths Medical recall is separate from two other device recalls the company issued this year. Smiths Medical recalled its Pneupac Parapac Plus ventilator kits in April, 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.

If a customer has experienced any adverse effects from a Smiths Medical Bivona tracheostomy tube, they are encouraged to contact the FDA’s safety information and adverse event reporting program at www.fda.gov/medwatch.