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The FDA has advised healthcare providers to stop using Medtronic's Nerve Integrity Monitoring (NIM) Standard and Contact EMG endotracheal tubes due to blockage risks. Medtronic recalled these tubes and instructed customers in a July letter to remove and return them. These products are no longer available for sale or distribution.
Between March 31, 2020, and May 20, 2024, Medtronic received 77 complaints. Airway obstruction risks associated with these devices could lead to brain injury and death. A 2022 safety notice from Medtronic, classified as a Class I recall by the FDA, reported three injuries and two deaths related to overinflation of the silicone cuff.
In January, Medtronic issued updated usage instructions and began training to reduce risks. The company has now halted tube shipments and canceled all orders. The FDA reinforced this directive in a notice to healthcare providers.
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