Medhealth Review

Medtronic Forced to Recall their Endotracheal Tubes After Complaints of Airway Obstruction

In an incident that the FDA, Food and Drug Administration termed a Class 1 event, the most severe kind of recall, Medtronics, a medical device firm, had to recall endotracheal tubes from across the globe. 

The American medical firm termed the incident “rare instances of serious adverse events related to certain EMG endotracheal tubes.” Medtronics is a worldwide leader in medical services, technology 

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The recall will be applicable worldwide. It seems the company will have to recall more than 6 25,000 tubes across the globe. The devices are made to extend an open ventilation airway. The other function of these tubes is to observe the recurrent laryngeal nerve during surgeries.

Medtronics, in its response, said that the matter is still under investigation, and research is still happening about what caused the incident.

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However, Medtronic also said, “We believe the NIM EMG tubes are safe when used according to the instructions for use.”

Customers were notified through an e-mail that explained what remedial measures to be undertaken if they encountered an airway obstruction. Also, the customers were not obliged to return or replace the recalled devices.

Customers were also given information to caution while changing the tube’s position. It is also necessary to deflate the cuff before changing the tube position or, if needed, the patient using the tube.

It appears that healthcare providers were issued a letter by the FDA that mentioned the details of the complaints about the medical devices. 

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