Medtronic issued a notification to inform the public of stolen defective McGRATH MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms.
These affected products did not pass Medtronic’s quality tests established for the product, were not released for sale, distribution, or importation, and were designated for destruction. These affected products are defective and should not be used.
Medtronic says in a notification posted on the US Food and Drug Administration’s (FDA) website that it is working closely with regulatory authorities and law enforcement organizations to help ensure that unauthorized advertisements are being removed as identified, and actions to recover the stolen defective products are underway.
The McGRATH MAC video laryngoscope is a device used to facilitate intubation of the trachea. The use of a defective McGRATH MAC video laryngoscope may result in patient harm, including failed laryngoscopy and/or intubation, potentially resulting in respiratory failure (including hypercarbia), hypoxia (leading to bradycardia, dysrhythmias), hypercapnia, tissue damage/tissue trauma, and/or a delay to treatment (prolonged procedure/extended hospitalization).
A population of products affected by this notice are marked with the serial numbers listed here. Additionally, any McGRATH MAC video laryngoscopes without a serial number marked on the device are affected by this notice.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax at 1-800-FDA-0178.
McGRATH MAC video laryngoscopes purchased directly from Medtronic or via its authorized distributors are not affected by this safety notice.