Medtronic has recalled specific endotracheal tubes after receiving complaints about blockages leading to serious health risks, prompting an FDA alert to health care providers.
RT’s Three Key Takeaways:
- Urgent Recall Due to Blockage Issues: Medtronic has recalled all NIM Standard and Contact EMG endotracheal tubes due to blockage issues that pose significant health risks, including airway obstruction and respiratory distress.
- FDA Alert and Recommendations: The FDA has alerted health care providers to stop using the affected tubes immediately and follow Medtronic’s instructions for removal and return of these products from their inventory.
- Serious Health Hazards Reported: Complaints about the recalled tubes include potential risks such as hypoxia, respiratory arrest, and even death.
The US Food and Drug Administration (FDA) is alerting health care providers and facilities to stop using NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes by Medtronic.
According to the FDA alert, on July 9 Medtronic issued an Urgent Medical Device Recall notice for removal of these endotracheal tubes from inventory due to issues with tube blockage.
Medtronic has received complaints indicating potential health hazards from degraded or complete loss of functionality of the endotracheal tubes with all models and lots.
The potential risks associated with use of these devices can include airway obstruction, unintended extubation, bronchospasm, hypoventilation, low oxygen saturation, hypoxia, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, respiratory arrest, cardiac arrest, brain injury, and death.
These neural integrity monitor (NIM) electromyogram (EMG) endotracheal tubes are used during surgery to provide an airway for patient ventilation and to monitor EMG activity and the nerve integrity of the thyroarytenoid muscle of the larynx.
FDA Issues Letter to Health Care Providers
The FDA issued a letter to health care providers to ensure they are aware of the manufacturer’s recall notice and the recommended actions.
The FDA recommends health care providers:
- Review the Urgent Medical Device Recall notice from Medtronic for removal from inventory of all NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes. This notice includes model numbers and Unique Device Identifier (UDI) information.
- Do not use NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes.
- Return affected products in your inventory to Medtronic.
- Report any issues with these devices to the FDA.
The FDA notes in the letter that it will continue to work with Medtronic to help ensure that health care providers and facilities are notified to stop using the recalled products and that it will continue to keep health care providers and the public informed if significant new information becomes available.
