According to a recall update announcement from the U.S. Food and Drug Administration has upgraded its recall classification of Medtronic endotracheal tubes to a Class I recall. The initial recall began in April 2022. However, the U.S. FDA has received two adverse incident reports that state the recalled endotracheal tubes have recently caused the deaths of two […]
Medtronic Endotracheal Tube Lawsuits
According to a recall update announcement from the U.S. Food and Drug Administration has upgraded its recall classification of Medtronic endotracheal tubes to a Class I recall. The initial recall began in April 2022. However, the U.S. FDA has received two adverse incident reports that state the recalled endotracheal tubes have recently caused the deaths of two patients. Food and Drug Administration officials issued a new warning letter concerning the risk of airway obstruction with some Medtronic electromyogram endotracheal tubes, and the agency re-categorized the recall as a Class I event. The FDA also stated that three patients sustained injuries related to airway obstruction complications with the Medtronic electromyogram endotracheal tubes.
The FDA has provided new recommendations about how to prevent airway obstruction and how to respond to these potentially fatal events when using Medtronic’s NIM Standard Reinforced EMG Endotracheal Tubes or its NIM CONTACT Reinforced EMG Endotracheal Tubes. Medical professionals are urged to review Medtronic’s letter and are asked to immediately “deflate the cuff and try to ventilate in the event of airway obstruction.”
Should medical professionals not be able to re-established ventilation when airway obstruction has occurred, the FDA is urging medical professionals to take out the endotracheal tube from the patient and then re-establish ventilation using a laryngeal mask airway or bag valve mask. The FDA also recommended re-intubating the patient using a non-silicone endotracheal tube. Should an EMG endotracheal tube be needed for surgery, medical professionals may use a bigger tube, requiring “less cuff inflation volume and pressure.”
A Class I recall is the most severe class of recall and is declared when a product or medical device can cause severe injuries or death.
More than 53,000 Medtronic NIM CONTACT Reinforced EMG Endotracheal Tubes and the NIM Standard Reinforced EMG Endotracheal Tubes are being recalled inside of the United States. These medical devices were manufactured and distributed for April 26, 2018, until April 15, 2022. Medtronic issued the recall on April 29, 2022.
The NIM Standard Reinforced EMG Endotracheal Tubes and the NIM CONTACT Reinforced EMG Endotracheal Tube are used during surgical procedures to:
The recall update states that Medtronic initiated the recall of its NIM CONTACT Reinforced EMG Endotracheal Tubes and NIM Standard Reinforced EMG Endotracheal Tubes after the company received several customer complaints about endotracheal tube obstruction when used in patients. Should the endotracheal tube become obstructed, ventilation failure may occur. When the endotracheal tube fails to ventilate the patient properly or obstructs the patient’s airway, the affected patients might sustain oxygen deprivation, brain damage, or death.
Medtronic has reported that their company has received at least fifteen complaints, with a total of three injuries and two deaths connected with the defective endo tubes.
Medtronic’s safety letter also advises medical professionals to:
Medtronic’s safety alert letter also recommended the following actions if an airway obstruction happens:
Medtronic stated that it is mailing an update concerning the current instructions in order to reinforce these precautions and warnings. Before launching this recall, the FDA issued a Letter to all Health Care Providers about the possible “Risk of Airway Obstruction” when using some electromyogram endotracheal tubes.
Did you or a loved one sustain harm due to a recalled endotracheal tube? Parker Waichman LLP helps those who have suffered product injuries receive full monetary compensation. Trust your case with our product injury lawsuit lawyers. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
