Smiths Medical is recalling certain tracheostomy tubes due to a defect that has been linked to two deaths and 35 injuries.

RT’s Three Key Takeaways:

  1. Smiths Medical has recalled specific Bivona neonatal/pediatric and adult tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear.
  2. The defect has been linked to two deaths and 35 injuries, prompting the FDA to classify this recall as the most serious type.
  3. Smiths Medical has advised customers to stop using the affected products, dispose of them, and follow the provided instructions for replacement or credit.

Smiths Medical is recalling specific lots of Bivona neonatal/pediatric and adult tracheostomy tubes due to a manufacturing defect that may cause the securement flange of the device to tear.

The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of a protected airway, and death. The US Food and Drug Administration has identified this recall as the most serious type. There have been 35 reported injuries and two reports of death.  

Bivona neonatal/pediatric and adult 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.  

Recalled products: 

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

On May 29, Smiths Medical sent all affected customers an Urgent Medical Device Notification recommending the following actions: 

  • Pay attention to instructions, warnings, and cautions outlined in the Instructions for Use. 
  • Check all inventory for affected product.
  • Do not use affected product.
  • Throw away all affected products according to the institution’s usual process.
  • Share the notification with all potential users of the devices, including other places the devices may be used. 
  • Complete and return the Customer Response Form to [email protected] within 10 days of receipt. 
  • Contact the local Smiths Medical representative for help with replacement product and/or credit. 
  • Distributors should immediately share this notice with any customers who may have received affected product. Those customers should complete the response form and return it via email.Â