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.
Affected Product
- 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
What to Do
- Assess the overall patient risk when considering the timing of replacement.
- Continue to follow current product Instructions for Use (IFU) along with facility specific policies and procedures.
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.
- Share this notice with all those who need to be aware within your organization and to any organization where potentially affected product from the specified lot has been transferred or distributed.
- Complete and return the Customer Confirmation Form attached to the letter even if you do not have unused inventory.
Reason for Recall
Medtronic and its subsidiary Covidien are recalling Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula because the tube may become dislodged or move out of place if the securement flange becomes disconnected. This could prevent the patient from breathing and/or block the airway, which may lead to a serious or life-threatening emergency.
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 related to this issue.
Device Use
The Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff and reusable inner cannula is used to help patients breathe by providing access to the windpipe (trachea). It can also be used during a procedure called Percutaneous Dilatational Tracheotomy (PDT), which is a method to create an opening in the neck to place the tube.
Contact Information
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.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
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.
