Dive Brief:
- Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration.
- The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot. The recall applies to the Shiley adult flexible tracheostomy tube with taperguard cuff reusable inner cannula.
- Medtronic began the recall after receiving reports from customers that the flange used to secure the device may become disconnected. Patient harm was reported in some cases, but no deaths have been reported to date, a company spokesperson wrote in an email Thursday.
Dive Insight:
Medtronic’s tracheostomy tubes are used to help patients breathe. They can also be used during a procedure to create an opening in the neck to place the tube. For the recalled devices, the securement flange may become disconnected, which can cause the tube to become dislodged and affect a patient’s breathing.
Using a device that has a disconnected flange can cause respiratory failure, airway tissue injury, choking, respiratory tract infection, tightening of the airways, treatment delay or death, according to the FDA notice.
For patients with affected devices already in place, a replacement is required, according to a March 25 entry in the FDA’s recall database. The product removal applies to 780 devices distributed outside of the U.S. in countries including France, Germany, South Africa, Spain and Taiwan, according to the entry.
The tracheostomy tubes were last recalled in 2023 due to a manufacturing error that could cause the tubes not to securely attach. The Class I recall required devices to be returned to Medtronic and affected nearly 600,000 products worldwide.
