The FDA has identified the type of recall as serious, with a risk of injury or death when continuing to use the device, according to a Sept. 5 news release from the agency. Local guidelines advise for first generation McGrath MAC and EMS Video Laryngoscopes to have the battery assembly removed and thrown away.
Medtronic sent all affected customers an Urgent Medical Device Sale Removal and Correction Letter recommending the return of devices to Medtronic after disposing of the battery assembly.
“Medtronic has initiated a voluntary removal for first generation McGrath MAC video laryngoscopes item codes 300-000-000 and 300-200-000,” director of communication’s for Medtronic Pamela Lee told Becker’s. “The next generation McGrath MAC video laryngoscopes (item code 301-000-000) and the McGrath 3.6V battery assembly (item code 340-000-000) are not included in the recall and can continue to be used for patient care.”
There has been one reported injury, the release said.
Editor’s note: This story was updated at 6:02 pm CT to reflect the specific product types affected by the recall.
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