This recall involves removing certain devices from where they are used or sold as the device may cause serious injury or death if people continue using it. It also includes updating instructions for using other models of these devices without removing those.
The McGrath Mac and Mac EMS video laryngoscopes help care providers see into the trachea during a medical procedure. The device features a light source and miniature camera to view the larynx during laryngoscopy.
Medtronic recalled the devices and updated the instructions on others due to the possibility that the battery may deplete below its designed threshold. If this happens, it increases the risk of battery instability. This may lead to increased battery temperature and a potential explosion.
Using affected products can cause serious adverse health consequences, such as burns, cuts, scarring and other tissue injuries. It could also lead to tooth loss, eye injury, damaged hearing, tinnitus, respiratory failure, hypoxia and death.
Medtronic reports one injury and zero deaths related to this issue.
More details on the Medtronic laryngoscope recall
According to the FDA notice, the removal recall affects McGrath Mac and McGrath Mac EMS video laryngoscopes. Models include 15060272980020/300-000-000 and 15060272980129/300-200-000. The recall affects all serial numbers of these devices between 366170 and 405673.
The instruction updates extend to the next-generation McGrath Mac video laryngoscope. That includes models 10884521823396/301-000-000 and 10884521776494/301-000-000.
For the recalled scopes, Medtronic instructed customers to not use the devices. They should remove the battery assembly and throw it away according to local guidelines. For the next-generation scopes with updated instructions, customers should review the updated battery handling addendum.
This addendum includes instructions to not use the battery past the “use by date” and to follow proper battery storage conditions. Customers should dispose of battery assemblies and replace with a new one if they don’t adhere to storage condition guidelines or if they drop the battery assembly.
Medtronic issued an urgent medical device removal and correction letter alerting customers in July. For recalled items, users should return the devices after disposing the battery assembly. Customers may continue using the next-generation scopes while adhering to the updated instructions for use.
Not the first issue with the McGrath Mac laryngoscopes
Last year, Medtronic faced another Class I recall for the scopes after warning on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall in October 2023 as a result of the stolen, defective products.
The recall affected 5,709 devices in the U.S., distributed between July 5, 2019, and July 14, 2022. Medtronic’s Covidien business initiated the recall on Sept. 28, 2023.
According to the FDA, defective laryngoscope sales occurred on social media platforms, including Facebook Marketplace. After the theft of the defective models was discovered, some devices were retrieved, and a Facebook Marketplace post was taken down. However, the FDA says where the devices were distributed remains unknown.
The agency said it received no complaints regarding the device issue. Medtronic indicated no reports of injuries or death related to it. The FDA notice said all defects and failure models aren’t known to the firm because they were stolen from the intended scrap.
