FDA Identifies Bivona Tracheostomy Tube Recall as Most Severe Type

The FDA has identified a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes as the most serious type.

The agency urges people to not use Bivona tracheostomy tubes from the affected lot numbers and to throw them away.

The reason for the recall is “a manufacturing defect that may cause the securement flange of the device to tear.” The use of the affected devices “may cause serious adverse health consequences, including lack of proper ventilation, loss of a protected airway, and death. There have been 35 reported injuries” and two reports of death.

The tracheostomy tubes are used “to provide direct airway access for a patient with a tracheostomy for up to 29 days. Some tubes can be reprocessed and re-used several times for a single patient.”