Medtronic’s silicone EMG endotracheal tubes have been linked to reports of airway obstruction, brain damage, and deaths, according to the FDA.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting silicone EMG endotracheal tube induced injury cases in all 50 states. If you or somebody you know has been injured or died from a Medtronic Silicone EMG Endotracheal Tube, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
FDA Warning: Silicone Endotracheal Tubes Linked to Deadly Risks
In April 2022, the FDA issued a Letter to Healthcare Providers to warn about a risk of airway obstruction, brain damage and death when using silicone-based electromyogram (EMG) endotracheal tubes, including:
- Medtronic NIM Standard Reinforced EMG Endotracheal Tube
- Medtronic NIM Contact Reinforced EMG Endotracheal Tube
What is the Risk?
If the tube does not ventilate properly, it can block a patient’s airway and cause oxygen deprivation, brain damage, or death. Furthermore, reports of injuries and deaths are more frequent for silicone-based EMG tubes compared to EMG tubes made from PVC, the FDA said.
What Are EMG Endotracheal Tubes?
Medtronic® NIM silicone-based EMG Endotracheal Tubes are the only silicone-based EMG tubes currently sold in the U.S.
These devices are used to intubate a patient and provide an airway during surgery. They use electrodes to monitor nerves in the patient’s laryngeal muscles when connected to an EMG monitor.
Medtronic Used 510(k) Approval for Silicone EMG Tubes
Medtronic’s silicone EMG tubes were cleared through the 510(k) process, which is a controversial FDA-approval loophole that allows new products on the market without undergoing rigorous clinical trials, so long as they are “similar” to an existing device.
Silicone EMG Tubes Linked to Increased Risk of Death
Unfortunately, the silicone-based EMG tubes have been linked to an increased risk of airway obstruction, brain damage, and death compared to PVC-based EMG tubes. Investigators have yet to identify a root cause of the airway obstruction risks.
Potential Side Effects
- Airway obstruction
- Oxygen deprivation
- Ventilation failure in an emergency
- Brain damage
- Death
Do I have a Silicone Endotracheal Tube Lawsuit?
The Schmidt Firm, PLLC is currently accepting silicone EMG endotracheal tube induced injury cases in all 50 states. If you or somebody you know has been injured or died from a Medtronic Silicone EMG Endotracheal Tube, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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