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  5. Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion
  1. Medical Device Recalls

Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

This recall also involves updating instructions for using other models of these devices, and does not involve removing them from where they are used or sold. 

Affected Product  

McGrath MAC Video Laryngoscope with labels for 3.6v battery Use By Date and serial number.

McGrath MAC Video Laryngoscope with labels for 3.6v battery Use By Date and serial number.

For Device Removal: 

  • Product Names: McGrath MAC Video Laryngoscope, McGrath MAC EMS Video Laryngoscope 
  • Unique Device Identifier (UDI)/Model: 15060272980020/300-000-000 and  15060272980129/300-200-000 
  • Serial Numbers: All serial numbers between 366170 to 405673

For Use Instructions Updates:

  • Product Name: Next-Generation McGrath MAC Video Laryngoscope
  • Unique Device Identifier (UDI)/Models: 10884521823396/301-000-000 and 10884521776494/301-000-000

What to Do  

For McGrath MAC and MAC EMS Video Laryngoscopes 

  • Do not use these devices. 
  • Remove the battery assembly and throw it away according to local guidelines. 

For McGrath MAC Video Laryngoscope (Next Generation)

  • Note that these devices are not being removed. 
  • Review the updated battery handling addendum to the Instructions for Use before using the device. This update includes the following instructions: 
  • Do not use a battery past the “Use by date” found on the McGRATH 3.6V battery assembly (340-000-000).
  • Follow proper battery storage conditions found in the product Instructions for Use (IFU).
  • Dispose of battery assemblies according to local guidelines and replace with a a new McGrath 3.6V labeled battery assembly if:
    • The battery assembly has not been stored in the conditions outlined in the IFU.
    • The battery assembly was dropped.

In July 2024, Medtronic sent all affected customers an Urgent Medical Device Removal and Correction letter recommending the following additional actions: 

For McGrath MAC and MAC EMS Video Laryngoscopes 

  • Return the devices (300-000-000 and 300-200-000) to Medtronic after disposing of the battery assembly according to local guidelines.

For McGrath MAC Video Laryngoscope (Next Generation)

  • Continue using Next-Generation McGrath Video Laryngoscopes (301-000-000).
  • Follow Important Battery Handling Information in the IFU and provided in the notice.
  • Keep a copy of the IFU addendum with the original IFU.

For all devices (regardless of removal or updated IFU)

  • Pass this notice on to all who need to be aware within the organization or to any organization where the affected product may have been transferred or distributed.
  • Complete the enclosed Customer Confirmation Form even if you do not have affected inventory.

Reason for Removal and Updates to Use Instructions   

Medtronic is recalling certain devices and updating use instructions for another due to the possibility that the battery may deplete below its designed threshold. If this happens, it increases the risk of battery instability and may lead to increased battery temperature and a potential explosion. 

The use of affected product may cause serious adverse health consequences, including burns, cuts (lacerations), scarring and other tissue injuries, tooth loss, eye injury, damaged hearing (impairment or acoustic shock) or ringing in the ears (tinnitus), respiratory failure, lack of oxygen to the body (hypoxia), scarring, and death.  

There has been one reported injury. There have been no reports of death.  

Device Use 

The McGrath MAC and MAC EMS Video Laryngoscopes are used to help care providers see into the trachea during a medical procedure. The devices include a light source and a miniature camera to view the voice box (larynx) during laryngoscopy.

Contact Information  

Customers in the U.S. with questions about this recall should contact their Medtronic representative or Customer Service at 800-962-9888, Option 2.

Additional FDA Resources:  

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

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. 

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