VerathonThe FDA has declared the recall of a Verathon video laryngoscopy system is Class I, the most serious kind.

Verathon’s GlideScope Core OneTouch smart cable  is designed to offer views of the airway and vocal cords for medical procedures. The system’s Core OneTouch smart cable is used to connect the GlideScope spectrum single-use video laryngoscopes and the GlideScope video baton 2.0 to the company’s Core 10 and Core 15 video monitors.

According to an FDA statement, Verathon recalled the cable because of the potential for temporary or complete loss of image when used with the aforementioned video monitors. An interruption of the video signal during use could cause serious adverse health consequences, including hypoxia and death, the agency said.

Verathon received 74 total complaints about the devices, while the FDA confirmed 9 medical device reports related to the issue. However, no injuries or deaths were reported in connection with the complaints.

The affected products fall under the part number 0800‐0601 and were manufactured from Sept. 17, 2019, to April 22, 2020. The devices were then distributed between Jan. 17, 2020, and April 22, 2020, before the company began its recall on May 6, 2020. To date, 356 devices have been recalled in the U.S.

Verathon sent a field safety notice to affected customers on June 5, 2020, urging users to locate and discontinue use of all affected products. When replacements are received, customers were told to then destroy or return all affected smart cables.