Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.
Medtronic and its subsidiary, Covidien, are recalling the Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula as the tube may become dislodged or move out of place if the securement flange becomes disconnected, according to a medical device recall notification from the US Food and Drug Administration.
This could prevent patient breathing and/or block the airway, which may lead to a serious or life-threatening emergency.
On Feb 26, 2025, Medtronic sent all affected customers an Urgent Medical Device Recall notice regarding the affected tracheostomy tube, recommending the following actions:
- Quarantine all unused product from the affected lot of Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula.
- Return all unused product from the affected lot in your inventory to Medtronic as described on the Customer Confirmation Form.
The use of a device that has disconnected the flange from the device cannula may result in respiratory failure, airway tissue injury, choking, respiratory tract infection, tightening of the airways, treatment delay, and/or death.
Medtronic has not reported any serious injuries or deaths associated with this issue.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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