The FDA has issued a release regarding a recall of the McGrath MAC Video Laryngoscope and the McGrath MAC EMS Video Laryngoscope, identifying it as “the most serious type” of recall.
Users are advised to “not use” the two devices and to “remove the battery assembly and throw it away according to local guidelines.” After doing so, the devices should be returned to Medtronic.
The reason for the recall is that there is a 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.” There has been one reported injury so far, but no reports of death.
The release also makes clear that McGrath MAC Video Laryngoscopes (Next Generation) are not being removed. Users of this device are advised to “review the updated battery handling addendum to the Instructions for Use” before use, and to “not use a battery past the ‘Use by date’ found on the McGRATH 3.6V battery assembly.” The agency also urges users of these devices to “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.”
Matt MacKenzie | Associate Editor
Matt is Associate Editor for Healthcare Purchasing News.
