FDA – August 8, 2020 – According to an online FDA Class I Recall Notice, the GlideScope® Core One™ TouchSmart Cable (also known as the “OneTouch cable”) system has been declared a Class I recall by the U.S. Food and Drug Association (FDA). An FDA Class I recall is the most severe class of FDA recall. A Class I recall means that the FDA is warning the public about a product, drug, or medical device that can injure or cause death to the user.
The GlideScope Core OneTouch smart cable was developed to provide video of a patient’s vocal cords and airway during surgical procedures in the patient’s throat. These GlideScope spectrum “single-use” video laryngoscopes feed video to the company’s surgery video monitors. However, the FDA reports that Verathon is recalling the cables due to the issues concerning the complete or temporary loss of the video when used with the company’s Core 10 and Core 15 video monitors. If the video signal is interrupted during use, this may cause severe health consequences such as hypoxia, brain damage, and death.
The company has received over 70 complaints about the video laryngoscope devices. The FDA has reported nine adverse medical reports that were related to the defect.
The recalled OneTouch smart cable has a part number of 0800‐0601 and were manufactured from September 17, 2019 until April 22, 2020. The video laryngoscope devices was recalled by Verathon on May 6, 2020. Verathon has recalled over 350 of these defective devices so far in the United States.
A field safety notice provided by Verathon was delivered to purchasers on June 5, 2020. The letter is urging purchasers to find and discontinue the use of these defective video laryngoscopes. Customers were shipped replacements and they have been asked to either return the defective smart cables to the manufacturer or destroy the defective smart cables to prevent use.
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