FDA labels Medtronic recall of some endotracheal tubes as Class I

The FDA this week said the Medtronic recall of some NIM Contact Reinforced EMG endotracheal tubes is Class I, the most serious kind.

Medtronic is recalling its NIM Contact Reinforced EMG endotracheal tubes and NIM Standard Reinforced EMG endotracheal tubes due to reports of obstruction of the endotracheal tube while in use in patients. Tube obstruction could result in ventilation failure and oxygen deprivation, brain damage or death.

Medtronic has received 15 complaints, including three injuries and two deaths associated with the recall between March 31, 2020, and March 31, 2022, according to an FDA warning letter.

The recall involves 53,029 devices in the U.S. and 339,260 devices outside the U.S. that were distributed between April 26, 2018, and April 15, 2022. Patients who are intubated using endotracheal tubes and clinicians who intubate patients using the tubes are affected by the recall.

All lots of the endotracheal tubes with UDIs 00643169789548, 00643169789531, 00643169789524, 00613994415462, 00613994415431, 00613994415455, 00643169789579, 00643169789562 and 00643169789555 are recalled.

More about the Medtronic endotracheal tubes recall

The NIM Contact and Standard Reinforced EMG endotracheal tubes are used during surgery to provide an airway for patient ventilation and monitor electromyogram activity and the nerve integrity of the thyroarytenoid muscle of the larynx.

The company is advising providers to intubate the patient using the standard of care and medical training and use care when manipulating the tube’s position, as manipulation could cause the inflated cuff to stretch over the tube opening potentially causing obstruction to the patient’s airway. The company also advised deflating the cuff before any manipulation or repositioning of the tube or patient.

Medtronic said providers should immediately deflate the cuff and attempt to ventilate if an airway obstruction occurs using the devices. If ventilation cannot be re-established, the company said providers should extubate the endotracheal tube from patients, re-establish ventilation with a bag valve mask or laryngeal mask airway and reintubate with a new non-silicone endotracheal tube or reintubate with a new, larger NIM Standard Reinforced EMG or NIM Contact Reinforced Endotracheal tube.

The company is mailing updated instructions reinforcing the warnings and precautions to customers.