Medtronic is issuing this 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 rigorous 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 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 (Item Code 301-000-000) 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.
CONFORMING devices can be identified by the presence of serial number and packaged in either version of container shown.Medtronic
