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Sep 28, 2023FDA: Do Not Use Certain Medtronic Endotracheal Tubes | Respiratory Therapy
Jul 9, 2024 | Recalls & Advisories, Therapy Devices |
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.
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:
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.
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Urgent Recall Due to Blockage Issues:FDA Alert and Recommendations:Serious Health Hazards Reported:
