Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall

FDA has published a notice recalling certain Medtronic McGrath MAC video Laryngoscopes and updating the use instructions for others after the company identified increased risk for the battery to overheat and explode. The Class I recall covers the McGrath MAC and MAC EMS video laryngoscopes — for removal — as well as the McGrath MAC video laryngoscope (next generation) — for correction.

The laryngoscopes are used to help healthcare providers see into the trachea during a medical procedure. It includes a light source and a miniature camera to view the larynx during laryngoscopy.

Medtronic is recalling certain McGrath MAC video Laryngoscopes and updating the instructions for use (IFU) for another after it was found that the device battery may deplete below its designed threshold, increasing the risk of battery instability. If this were to occur, battery instability may lead to increased battery temperature and a potential explosion.

Use of affected devices could result in burns, cuts, scarring and other tissue injuries, tooth loss, eye injury, damaged hearing, tinnitus, respiratory failure, lack of oxygen to the body, and death. Currently there has been one reported injury and no deaths associated with this issue.

“Medtronic has initiated a voluntary removal for first generation McGrath MAC video laryngoscopes item codes 300-000-000 and 300-200-000,” a Medtronic spokesperson told MD+DI. “This removal follows two customer complaints and is 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. There have been no reports of patient harm in relation to this issue; however, one customer report indicated there was caregiver injury.”

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In July, Medtronic sent all affected customers an Urgent Medical Device Removal and Correction letter recommending that they should not use the McGrath MAC and MAC EMS video laryngoscope, remove and dispose of the battery assembly according to local guidelines, and return the device to the company.

“The safety and well-being of patients and customers is our top priority,” according to the company spokesperson. “We have advised customers to discontinue use of all affected serial numbers of first-generation McGrath MAC video laryngoscopes and remind customers not to use the devices beyond their five-year product life. Returned affected first-generation McGrath MAC video laryngoscope devices within the five-year product life will be replaced with a next generation device at no cost to the customer.”

For the McGrath MAC video laryngoscopes (next generation), the company said that the devices can continue to be used. The IFU has been updated to include important battery handling information and it is recommended to keep a copy of the addendum with the original IFU.

The addendum includes updates such as:

“The next generation Mc 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,” the spokesperson told MD+DI. “Next-generation McGrath MAC video laryngoscopes include an advanced battery management system that maintains the battery within intended voltage usage levels and renders them inoperable when the battery voltage falls below the device design threshold.”