FDA and Medtronic issue recall on endotracheal tubes due to risk of death
Providers and hospitals are warned by the U.S. Food and Drug Administration (FDA) to immediately stop using Medtronic EMG Reinforced Endotracheal Tubes after multiple customers reported the devices degraded or completely lost functionality.
Medtronic issued the alert to its customers on July 9, with instructions to remove them from inventory due to a serious risk of patient injury or death. The FDA is working with Medtronic to have all defective tubes recalled, the agency said in a statement.
The tubes are used to open airways during emergency procedures and surgeries. There was no mention of injuries. However, the tubes potential to cause blockages of the airway could lead to unintended extubation, bronchospasm, hypoventilation, low oxygen saturation, hypoxia, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, respiratory arrest, cardiac arrest, brain injury and potentially the death of a patient.
What is being recalled?
All Medtronic NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes are being recalled.
In its notice the company provided a full list of impacted products and their unique identification numbers. That can be found here.
Next steps
Providers are advised to immediately stop using the endotracheal tubes and seek alternatives. Defective products are to be returned to Medtronic for replacement. Supply houses are being told to cease their distribution.
Any customer in possession of Medtronic NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes is asked to fill out a customer confirmation form and contact Medtronic at neuro.quality@medtronic.com for replacements.
The FDA will continue to work with Medtronic until all dangerous products are removed from the market, the agency said. Customers who do not currently have any tubes in their possession but who forced to discard them are still asked to contact Medtronic at the above email.
Providers are also asked to post and share the FDA recall notice to increase visibility.
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