FDA Class I recall: Medtronic Xomed endotracheal tubes

Sept. 14, 2022

Medtronic Xomed is recalling the NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes after receiving customer complaints about obstruction of the endotracheal tube while in use in patients. If the tube obstructs, ventilation failure can occur.

If the tube does not ventilate properly or obstructs the airway, patients may suffer oxygen deprivation, brain damage, or death.

Medtronic Xomed reported that they have received 15 complaints, three injuries, and two deaths associated with this issue between March 31, 2020, and March 31, 2022.

·       Product Name: NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube

·        Model Numbers: See recall database entry

·        Devices Being Recalled in the U.S.: 53,029 and Outside the U.S.: 339,260

·        Dates distributed: April 26, 2018, to April 15, 2022

·        Date Initiated by Firm: April 29, 2022

Device Use

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes are used during surgery to:

·        Provide an airway for patient ventilation and

·        Monitor electromyogram (EMG) activity and the nerve integrity of the thyroarytenoid muscle of the larynx.

Who May Be Affected

·        Patients who are intubated using the NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes.

·        Clinicians who intubate patients using the NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes.

What to Do

On April 29, 2022, Medtronic Xomed issued an Urgent Medical Device Correction to anesthesia care providers and other users of these products. The letter emphasized the importance of following the instructions for use (IFU) and avoiding overinflation of the product’s silicone cuff to prevent airway obstruction.

Additionally, the letter advised providers to:

·        Intubate the patient using standard of care and medical training.

·        Use care when manipulating the tube’s position (as stated in IFU), as manipulation can cause the inflated cuff to stretch over the tube opening potentially causing obstruction to the patient’s airway.

·        Deflate the cuff before any manipulation or repositioning of the tube and/or patient.

The letter also offered recommended actions for care providers if an airway obstruction occurs:

·        Immediately deflate the cuff and attempt to ventilate.

·        If ventilation cannot be re-established:

o   Extubate the endotracheal tube from the patient

o   Re-establish ventilation with bag valve mask or laryngeal mask airway

o   Reintubate with a new non-silicone endotracheal tube or, if surgically needed, re-intubate the patient with a new, larger NIM Standard Reinforced EMG Endotracheal Tube or NIM CONTACT Reinforced EMG Endotracheal Tube which will require less cuff inflation volume and pressure.

Medtronic Xomed also noted that an update to the current instructions reinforcing these warnings and precautions will be mailed to customers.

FDA release

Illustration 95879673 © Sandamali Fernando | Dreamstime.com
Photo 202771086 © Kapil Joshi | Dreamstime.com
Photo 159538255 © Thanee Hengpattanapong | Dreamstime.com
Photo 144935703 © Andrey Metelev | Dreamstime.com