Medtronic’s Recall of Some McGrath MAC Video Laryngoscopes Is Class I

The U.S. Food and Drug Administration has tagged Medtronic’s recall of certain McGrath MAC video laryngoscopes as Class I, the most dangerous type of recall.
 
This recall involves removing lots of the McGrath MAC video laryngoscope and McGrath MAC EMS video laryngoscope with Unique Device Identifier (UDI)/Model 15060272980020/300-000-000 and 15060272980129/300-200-000 with serial numbers between 366170 to 405673.
 
Next-generation McGrath MAC products with UDI/Models 10884521823396/301-000-000 and 10884521776494/301-000-000 do not need removal, but Medtronic issued updated Instructions For Use (IFU) to continue their safe use.
 

Medtronic recalled the laryngoscopes and updated their IFU because of a possibility that the battery can deplete below its designed threshold. This increases risk of battery instability and can lead to higher temperature and a potential explosion.
 
The company advised using affected products can cause burns, cuts, scarring, and other tissue injuries, tooth loss, eye injury, damaged hearing or tinnitus, respiratory failure, hypoxia, scarring, and in worst cases, death.
 
As of today there has been one report of injury and none of death.
 
Medtronic’s July 24 Urgent Medical Device Removal and Correction Letter advised to return the affected lots of McGrath MAC and MAC EMS video laryngoscopes after properly disposing of the battery assembly. Next-generation McGrath video laryngoscopes can be used if the IFU’s Important Battery Handling Information is followed. A copy of the IFU addendum should be kept with the original IFU.
 
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 miniature camera to view the voice box (larynx) during laryngoscopy.