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Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula
The FDA is aware that Medtronic and its subsidiary, Covidien, is recalling its 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. 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 recommending the following actions:
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Quarantine all unused product from the affected lot of Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula.
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Return all unused product from the affected lot in your inventory to Medtronic as described on the Customer Confirmation Form.
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Complete and return the Customer Confirmation Form [attached to the Urgent Medical Device Recall notice] 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.
Medtronic has not reported any serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact their Medtronic Representative or Customer Service at (800) 962-9888 and select “Option 2” when prompted.
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