Medtronic Breathing Tube Recall Issued After Patient Deaths, Injuries: FDA

Nearly 400,000 Medtronic surgical breathing tubes have been recalled, following reports of multiple patient deaths and injuries linked to ventilation failures that were caused by airway obstructions.

The Medtronic Xomed Endotracheal Tube recall was announced by the FDA on September 12, indicating that clinicians intubating patients with the recalled breathing tubes need to avoid overinflating the silicone cuff, to avoid airway obstructions.

Officials reported that between March 31, 2020, and March 31, 2022, at least 15 complaints of problems with the Medtronic breathing tubes were reported, including three injuries and two deaths linked to an obstruction.

The recall includes Medtronic’s NIM CONTACT Reinforced EMG Endotracheal Tube, and the NIM Standard Reinforced EMG Endotracheal Tubes, which are used during surgical procedures to provide an airway for patient breathing and to monitor nerve activity. The devices are used in conjunction with an inflatable silicone cuff to allow insertion of the tubes.

Approximately 392,000 devices are impacted by the recall, of which 53,000 were distributed for sale in the United States and 339,000 were delivered to healthcare facilities and surgical centers in other countries. The products were distributed from April 26, 2018, to April 15, 2022.

Medtronic Xomed Endotracheal Tubes Linked to Airway Obstructions

According to the Class I recall notice, officials are warning clinicians that over-inflation of the silicone cuff may cause an obstruction of the breathing tube. Officials are also warning any manipulation of the tubing should be performed with caution as the inflated cuff could stretch over the tube, also causing an airway obstruction.

“If the tube does not ventilate properly or obstructs the airway, patients may suffer oxygen deprivation, brain damage, or death,” officials stated in the recall notice.

Medtronic issued an Urgent Medical Device Correction to anesthesia care providers on April 29, emphasizing the importance of following the instructions for use (IFU) to avoid potential airway obstructions.

The letter instructed healthcare providers to immediately deflate the silicone cuff and attempt to ventilate if an airway obstruction occurs. If the patient continues to experience an airway obstruction, Medtronic is advising to immediately remove the endotracheal tube from the patient and to ventilate with a bag valve mask or laryngeal mask airway.

Medtronic announced they will be providing an update to the current instructions reinforcing these warnings and precautions will be mailed to customers.

Customers with questions or concerns regarding the recall are being encouraged to contact their Medtronic Xomed Representative, and to report any adverse reactions or quality problems associated with the devices to the FDA’s MedWatch Safety Information and Adverse Reporting Program.

Medtronic MiniMed Pump Lawsuit

The recall comes amid a growing number of Medtronic MiniMed Pump lawsuits being filed for individuals who were hospitalized due to an insulin pump failure or device malfunction that resulted in hypoglycemia, hyperglycemia, diabetic coma and or wrongful death.

The pumps, which are small, computerized devices can be clipped to a belt or taped to the skin and use wireless transmissions to glucose monitors to measure the body’s glucose levels, then deliver insulin via a catheter tube, known as an infusion set, as needed. They are used to treat patients with both type 1 and type 2 diabetes.

However, design problems with the insulin pumps have resulted in a number of recalls due to severe and potentially life threatening injuries that may have resulted from an under dosing or overdose of insulin.

Major MiniMed recalls have been issued in 2009, 2013, 2014, 2017, and a Medtronic MiniMed 600 series recall, which affected more than 300,000 devices nationwide, was issued on February 12, 2020. This action was taken after more than 26,000 complaints of problems with the MiniMed pump were identified, including at least 2,175 injuries and one death. The FDA announced a Medtronic MiniMed 600 series recall expansion in early October 2021, increasing the number of affected devices to half a million.