NIM Standard Reinforced EMG

2022: Recall of defective endotracheal tubes

On September 2, 2022, it was reported that Medtronic was recalling endotracheal tubes after receiving reports of airway obstruction. A total of 625,700 devices distributed worldwide are subject to withdrawal, including NIM Standard Reinforced EMG endotracheal tubes and NIM CONTACT Reinforced EMG. The FDA agency assigned this recall to Class I. The devices are designed to provide an open airway for ventilation and to monitor the recurrent laryngeal nerve during operations.

Medtronic said in a statement that it was still assessing the details and root cause of reports of "rare cases of serious adverse events associated with certain EMG endotracheal tubes."

NIM Standard Reinforced EMG

We believe that the NIM EMG tubes are safe to use according to the application instructions, "the company said, adding that consumers should carefully review product instructions and that the company does not urge customers to return or replace recalled devices.

In April 2022, Medtronic sent a safety notice to consumers explaining what should be done in the event of airway obstruction.

The company also advised consumers to be careful when repositioning the tube and deflate the cuff before repositioning the tube or patient. Manipulation of the inflated tube can cause the inflated cuff to be pulled over the tube opening, which can also result in obstruction of the patient's airways.

Silicone-based EMG endotracheal tubes may have a higher rate of obstruction compared to other types of tubes, the FDA said in an April 2022 letter addressed to health care providers regarding Medtronic devices. The agency said it received reports of serious adverse events and deaths related to the devices after airway obstruction and ventilation failure.^[1]

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Шаблон:Remarks