Medtronic (NYSE: MDT) is recalling specific lots of its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff and reusable inner cannula due to an issue that could pose serious health risks.
The FDA labeled the recall as Class I, the most serious kind, because the device’s securement flange may detach from the cannula, potentially allowing the tube to become dislodged or move out of position. This issue can lead to respiratory failure, airway tissue injury, choking (aspiration), respiratory tract infection, tightening of the airways (bronchospasm), treatment delay, and/or death, according to the agency announcement.
Medtronic has not reported any serious injuries or fatalities to date.
The Shiley tracheostomy tube is used to maintain airway access in patients and during procedures such as percutaneous dilatational tracheotomy. Potential complications from flange disconnection include airway injury, bronchospasm, treatment delays, and aspiration.
The specific devices affected
The recall affects devices under the product name Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, with UDI numbers A8845212054401, 20884521205441, and 10884521205444, and lot number 202405258X.
Medtronic notified customers of the issue in a letter dated February 26, urging healthcare providers to immediately quarantine and return unused devices from the affected lot.
Facilities have been advised to assess patient risk before removing in-use devices and to continue following the device’s instructions for use and institutional protocols.
