US Food and Drug Administration (FDA) Recall of Medtronic Removes Shiley Adult Flexible Tracheostomy Tube

U.S. Food and Drug Administration Product Recall Alert!

The Office of Developmental Programs (ODP) is sharing this important announcement from the U. S. Food and Drug Administration (FDA).

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 Office of Developmental Programs (ODP) is sharing this important announcement from the U. S. Food and Drug Administration (FDA).

Summary

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.

BACKGROUND

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.

• Product Names: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula
• Unique Device Identifier (UDI): A8845212054401, 20884521205441, 10884521205444
• Lot/Serial Numbers: Lot: 202405258X, SKU/CFN: 7CN80R

RECOMMENDATIONS 

On Feb. 26, 2025, Medtronic sent all affected customers an Urgent Medical Device Recall notice 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.
• Complete and return the Customer Confirmation Form [attached to the Urgent Medical Device Recall notice] even if you do not have unused inventory.

Refer to the FDA Original Press Release at 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 | FDA for instruction on requesting a replacement and additional information.