The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product (Include the following information)

• Product Names: McGRATH™ MAC Video Laryngoscopes
• Product Codes: See Recall Database Entry
• Item Code: 301-000-000
• Distribution Dates: July 5, 2019 to July 14, 2022
• Devices Recalled in the U.S.: 5,709
• Date Initiated by Firm: September 28, 2023

Device Use

The McGRATH™ MAC video laryngoscope is a tool used by trained and licensed individuals to gain a view of the vocal cords during medical procedures, typically a laryngoscopy. The device incorporates a light source (LED) and miniature camera (camera) to view the larynx during medical procedures.

Reason for Recall

Covidien LLC is recalling McGRATH MAC Video Laryngoscope in order to remove stolen defective models that have been offered for sale illegally by unauthorized third parties. These Laryngoscopes, meant for destruction, were being sold on social media platforms.

After the theft was discovered, some devices were retrieved, and a for sale posting on FaceBook Marketplace was taken down. However, it is unknown where the devices were distributed.

There have been no complaints regarding this devices issue. The firm indicates no injuries and no deaths have been reported for this issue.

All the defects and failure modes are not known to the firm because they were stolen from the intended scrap.  As such, it is not possible to 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.

Who May be Affected

• People who have medical procedures that involve the use of the McGRATH MAC Video Laryngoscope
• Health care providers who use McGRATH MAC Video Laryngoscope

What to Do

On September 28, 2023, Medtronic posted a Public Safety Notification on their company website to communicate the following:

• Not use any product not packaged in the labeled packaging containers or without a serial number marked on the device.
• Purchase products only from trusted and reliable sources, such as directly from Medtronic or its authorized distributors.
  • To find an authorized distributor or to purchase directly from Medtronic, contact Customer Service at 800-962-9888, Option 2.

Anyone with information regarding the promotion or sale of potentially stolen products are encouraged to contact Medtronic Customer Service at 800-962-9888, Monday through Friday from 8AM to 7PM ET.

Contact Information

Customers in the U.S. with questions about this recall should contact Medtronic Customer Service at 800-962-9888

Additional Resources

• Class 1 Device Recall Stolen McGRATH MAC Video Laryngoscopes
• Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes (Medical Device Recalls Database)
• Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes (FDA.gov)

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.