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.

  • 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

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.

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.