The company is also updating use instructions for another due to an increased risk of battery overheating and explosion.

Summary: Medtronic is recalling certain McGrath MAC video laryngoscopes and updating usage instructions for another due to potential battery overheating, which could lead to serious safety risks, including burns, scarring, respiratory failure, and in extreme cases, death. The recall, identified by the FDA as the most serious type, involves removing the affected devices and providing updated instructions for next-generation models to prevent battery instability. Medtronic has notified customers and issued guidelines for proper device disposal and handling.

Key Takeaways:

  1. Product Recall Due to Battery Risks: Medtronic is recalling specific McGrath MAC video laryngoscopes because the batteries in these devices could overheat and potentially explode, posing severe safety risks to patients and users.
  2. Medtronic Removes Certain Devices: Medtronic is removing McGrath MAC and MAC EMS video laryngoscopes due to battery instability risks, instructing users to dispose of the battery assembly and return the devices.
  3. Updated Instructions for Next-Generation Devices: The next-generation McGrath MAC video laryngoscopes are not being removed, but Medtronic has issued updated battery handling instructions to prevent potential risks, including proper storage and disposal guidelines.

Medtronic is removing certain McGrath MAC video laryngoscopes 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 the affected product may cause serious adverse health consequences, including burns, cuts, scarring and other tissue injuries, tooth loss, eye injury, damaged hearing,or ringing in the ears, respiratory failure, lack of oxygen to the body, scarring, and death.  

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

The US Food and Drug Administration has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Affected Product  

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.
    • Dispose of battery assemblies according to local guidelines and replace with 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, 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 instructions for use and provided in the notice.
  • Keep a copy of the instructions for use addendum with the original instructions for use.

For all devices (regardless of removal or updated instructions for use)

  • 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 a customer confirmation form even if you do not have affected inventory.

Customers in the US with questions about this recall should contact their Medtronic representative or customer service at 800-962-9888, option 2.