BY SEAN WHOOLEY

Conforming devices can be identified by their serial number.

The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT)+ McGrath Mac video laryngoscopes is Class I, the most serious kind.

Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products.
The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation.
Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment.
More details on the Medtronic recall
The recall affects 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. Because of this, the company can’t rule out the major failure modes that may lead to inadequate airway support, cardiopulmonary arrest, and death. Subpopulations at higher risk include those with higher metabolic rates and lower pulmonary reserve – pediatrics, pregnant, obese, critically ill.
Medtronic told customers not to use any product not packaged in the labeled containers or without a serial number. They should purchase products only from trusted and reliable sources, like directly from Medtronic or authorized distributors.