Critical recall: Medtronic tracheostomy tube

The FDA is alerting healthcare providers about a problematic tracheostomy tube that has potential for causing serious or life-threatening injury. 

The model is the Medtronic Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula. 

FDA says the product is at risk of sustaining dislodgement between its tube and its flange. Should that happen, the patient’s airway may become blocked, making respiration difficult or impossible. 

Due to the risk of such dire consequences, FDA has categorized the action as a Class I recall. This means there is a reasonable chance the product will cause serious health problems or death.

The agency notes that Medtronic has already notified all affected customers of the issue, having sent an urgent recall notice in February. 

At that time, Medtronic and its subsidiary Covidien instructed these customers to:

• Quarantine and then return all unused units to Medtronic;  
   
• Share the recall notice with all departments within the provider org that might have the units on hand; and 
   
• Complete and return a confirmation form attached to the recall letter “even if you do not have unused inventory.”

“The use of a device that has disconnected the flange from the device cannula may result in respiratory failure, airway tissue injury, choking (aspiration), respiratory tract infection, tightening of the airways (bronchospasm), treatment delay and/or death,” FDA further explains.

The agency adds that Medtronic has not reported any serious injuries or deaths related to this issue.

Additional details are here.