The neural integrity monitor electromyogram tubes are used during surgery to monitor EMG activity and provide an airway for patient ventilation, according to the agency. The devices are being recalled amid “reports of issues with tube blockage, consistent with cuff herniation, in some cases due to overinflation of the Endotracheal Tube cuff,” Medtronic said in a letter to customers.
Medtronic is recalling about 20 models because of the issue, which the FDA began investigating in April 2022. The company previously recalled about 390,000 of the NIM EMG tubes that were sold around the world.
The FDA did not specify whether any injuries have been reported.
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