NIM Standard (endotracheal tubes)

2024: Product Recall from the Market

In mid-July 2024, regulators urgently recalled defective endotracheal tubes manufactured by Medtronic from the market. Health professionals have been warned that the use of certain models of endotracheal tubes could lead to blockage of air flow and death of the patient, calling for their use to be phased out.

All versions and batches of NIM Standard and NIM Contact EMG endotracheal tubes were withdrawn from the market and the company said it had cancelled all orders it had received previously. These endotracheal tubes were intended for mechanical ventilation during surgery, as well as monitoring the integrity of laryngeal muscle neurons throughout the procedure.

DOTMed

Medtronic received 77 complaints of endotracheal malfunctions between March 2020 and May 2024 that resulted in airway obstruction, unintended extubation, decreased blood oxygen saturation and respiratory distress syndrome, according to a notice received by regulators. In addition, there were reports of respiratory arrest, cardiac arrest, cortical damage and death due to endotracheal tube malfunction.

Medtronic previously issued a safety notice for these devices in April 2022, which included warnings about the possibility of excessive inflation of internal tube cuffs, and in September 2022, regulators recalled almost 400,000 units of products distributed around the world. In January 2024, the company updated product labeling and issued additional notices to suppliers, as well as training materials on anesthesiology. The recall has not yet been officially classified, but regulators have confirmed that the use of these products is accompanied by the risk of serious injury or death.^[1]

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