Medtronic Issues Recall for Laryngoscope: Modifications Made to McGrath MAC IFU

Medtronic Issues Recall for Laryngoscope: Modifications Made to McGrath MAC IFU

Medtronic Issues Recall for Laryngoscope: Modifications Made to McGrath MAC IFU

This recall necessitates the withdrawal of specific devices from usage or sale. The FDA classifies this recall as critically severe. Continued usage of this device could lead to severe injury or mortality.

This recall also includes the revision of instructions for utilizing other models of these devices without necessitating their withdrawal from use or sale.

Products Affected  

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

McGrath MAC Video Laryngoscope featuring labels indicating 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)/Models: 15060272980020/300-000-000 and 15060272980129/300-200-000 
  • Serial Numbers: All serial numbers between 366170 to 405673

For Updates to Use Instructions:

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

Actions to Take  

Concerning McGrath MAC and MAC EMS Video Laryngoscopes 

  • Cease usage of these devices immediately. 
  • Remove the battery assembly and dispose of it in accordance with local regulations. 

For Next Generation McGrath MAC Video Laryngoscope

  • Understand that these devices are not subject to withdrawal. 
  • Examine the updated battery handling addendum in the Instructions for Use prior to utilizing the device. This update incorporates these guidelines: 
  • Do not employ a battery beyond the “Use by date” marked on the McGRATH 3.6V battery assembly (340-000-000).
  • Adhere to the correct battery storage guidelines outlined in the product Instructions for Use (IFU).
  • Dispose of the battery assemblies per local regulations and replace them with a new McGrath 3.6V labeled battery assembly if:
    • The battery assembly has not been stored in the specified conditions from the IFU.
    • The battery assembly has sustained drops.

In July 2024, Medtronic disseminated an Urgent Medical Device Removal and Correction letter to all affected customers outlining the following further actions: 

For McGrath MAC and MAC EMS Video Laryngoscopes 

  • Return the devices (300-000-000 and 300-200-000) to Medtronic following disposal of the battery assembly in line with local guidelines.

For Next Generation McGrath MAC Video Laryngoscope

  • Maintain usage of Next-Generation McGrath Video Laryngoscopes (301-000-000).
  • Observe Essential Battery Handling Information present in the IFU and supplementary notices.
  • Ensure you keep the IFU addendum along with the original IFU.

For all devices (regardless of removal or updated IFU)

  • Disseminate this notice to all relevant parties within the organization or to any organization that may have received the affected product.
  • Fill out the accompanying Customer Confirmation Form even if there is no affected stock.

Justification for Removal and Updates to Usage Instructions   

Medtronic is recalling specific devices and modifying use instructions for others due to a risk where the battery could deplete below its designed threshold. This condition could result in battery instability and can potentially lead to an increase in temperature and explosion risks. 

Utilization of affected products could lead to serious health implications, including burns, lacerations, scarring and various tissue injuries, loss of teeth, ocular injuries, hearing damage (impairment or acoustic shock), or tinnitus, respiratory failure, hypoxia, scarring, and even death.

One injury has been reported, but no fatalities have been documented.  

Device Purpose 

The McGrath MAC and MAC EMS Video Laryngoscopes facilitate healthcare professionals in visualizing the trachea during medical procedures. They integrate a light source and a miniature camera for viewing the larynx during laryngoscopy.

Contact Details  

US customers with inquiries regarding this recall should reach out to their Medtronic representative or contact Customer Service at 800-962-9888, Option 2.

Additional FDA Resources:  

  • FDA’s Enforcement Report 
  • Medical Device Recall Database 

Unique Device Identifier (UDI) 

The unique device identifier (UDI) enables the identification of individual medical devices in the United States from manufacturing through distribution to patient utilization. This identifier promotes more precise reporting, examination, and analysis of adverse event reports, facilitating quicker identification and resolution of device problems. 

What to Do If You Encounter Issues? 

Healthcare providers and consumers are encouraged to report adverse reactions or quality issues they face with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.