The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- 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
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.
Reason for Recall
Medtronic 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 reported that they have received 15 complaints, three injuries, and two deaths associated with this issue between March 31, 2020, and March 31, 2022.
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 issued an Urgent Medical Device Safety Notice 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:
- Extubate the endotracheal tube from the patient
- Re-establish ventilation with bag valve mask or laryngeal mask airway
- 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 also noted that an update to the current instructions reinforcing these warnings and precautions will be mailed to customers.
Prior to this recall, the FDA issued a related Letter to Health Care Providers about the Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes.
Customers with questions or concerns about this recall are asked to contact their Medtronic Representative.
- Medical device recall database
- Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers
How do I report a problem?
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.