United States
On September 28, 2023, Medtronic issued 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. McGRATH™ MAC video laryngoscopes purchased directly from Medtronic or via its authorized distributors are not affected by this safety notice.
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 below. Additionally, any McGRATH™ MAC video laryngoscopes without a serial number marked on the device are affected by this notice. The stolen defective products are not packaged in the labeled packaging containers shown below:
CONFORMING devices can be identified by the presence of serial number and packaged in either version of container shown.
Patient safety remains at the core of the Medtronic Mission to alleviate pain, restore health, and extend life. Medtronic urges healthcare professionals to purchase products only from trusted and reliable sources, such as directly from Medtronic or its authorized distributors.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Medtronic
Brand name: Medtronic
Product recalled: McGRATH MAC video laryngoscopes
Reason of the notification: Stolen Potentially Defective
FDA Recall date: October 19, 2023
Source:
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medtronic-notification-stolen-defective-products-potentially-defective-mcgrathtm-mac-video
