Medtronic Video Laryngoscopes Recall Results in “Do Not Use” Warning

FDA indicates that the batteries in Medtronic video laryngoscopes may overheat or explode, posing a risk of serious injury or death for patients.

Federal health officials are warning that recalled Medtronic video laryngoscopes can cause serious injuries if the batteries overheat or explode, potentially resulting in burns, respiratory failure or other life-threatening injuries.

The Medtronic laryngoscope recall was announced by the U.S. Food and Drug Administration (FDA) on September 5, urging medical providers not to use McGrath MAC Video Laryngoscopes, McGrath MAC EMS Video Laryngoscopes and Next-Generation McGrath MAC Video Laryngoscopes.

Laryngoscopes are devices used to help doctors see into the trachea during a medical procedure. They contain a tube with a camera inside that is placed down the trachea to view the larynx or voice box during laryngoscopy.

The agency has given the recall a class I designation, indicating that the laryngoscope battery problems pose a serious threat of injury or death to patients.

Medtronic Laryngoscope Battery Explosions

The FDA announced the laryngoscope recall after receiving numerous reports involving battery problems, and at least one instance that resulted in a patient injury. However, no reports of death have been linked to the Medtronic laryngoscope battery issues so far.

The recall pulls some Medtronic laryngoscopes from the market, and updates the use instructions for the batteries of other laryngoscopes.

Reports indicate the battery in the devices may drain below the designated threshold, which can cause the battery to become unstable and overheat, potentially leading to an explosion.

A laryngoscope battery explosion could cause serious injuries, such as burns, cuts, scarring, tissue injuries, tooth loss, eye injury, damaged hearing, ringing in the ears, respiratory failure, lack of oxygen to the body and death.

The recall completely pulls the McGrath MAC Video and MAC EMS Video Laryngoscopes from the market. The FDA warns that medical professionals should stop using the devices immediately, remove the battery from the device assembly, and throw it away. The devices should then be returned to Medtronic, according to the recall guidelines.

However, the McGrath Next-Generation MAC Laryngoscope is not being recalled from the market. Instead, the device’s use instructions are being updated, to provide additional information about battery handling in an addendum to the “Instructions for Use”.

The FDA indicates that health care professionals should not use any batteries past the “use by” date found on the McGrath 3.6V battery assembly and should follow proper handling and storage instructions.

Customers can replace the battery assembly with a new McGrath 3.6V battery, if the battery has not been stored in the improper conditions outlined in the updated instructions, or if the battery has not been dropped.

The updated use instructions were issued to all customers via an Urgent Medical Device Removal and Correction letter issued by Medtronic in July 2024.

The Next-Generation Laryngoscopes can continue to be used if the updated instructions and proper battery handling are followed.

The recall affects McGrath MAC Video Laryngoscopes and McGrath MAC EMS Video Laryngoscopes with unique device identifier/model numbers 15060272980020/300-000-000 and 15060272980129/300-200-000 and serial numbers 366179 to 405673.

The “for use” instruction updates affect Next-Generation McGrath MAC Video Laryngoscopes with unique device identifier/model numbers 10884521823396/301-000-000 and 10884521776494/301-000-000. Use by dates and serial numbers can be found on the labels for the 3.6V battery.

Customers can contact Medtronic with questions about the recall at 800-962-9888. Injuries and side effects can be reported to the FDA’s MedWatch Adverse Event Reporting system.