Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona Tracheostomy Tubes.
All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service. A copy of that letter as well as a list of affected products can be accessed on ICU Medical’s website here.
The customer notification sent on May 29, 2024, indicated that if the flange on the item is torn or broken, the tracheostomy tube may not stay in position in the trachea. This can lead to tracheostomy displacement or decannulation. Either event may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.
The U.S. Food and Drug Administration (FDA) has been notified of this action.
Adverse reactions or quality problems experienced with this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
