Verathon Inc. is recalling the GlideScope Core One TouchSmart Cable because of the potential for temporary or complete loss of image when used with Core 10 and Core 15 video monitors. If there is an interruption in the video signal during use, this may cause the patient to experience serious adverse health consequences, including hypoxia and death.
Verathon Inc. has received 74 complaints in total about these devices, and the FDA has received 9 Medical Device Reports (MDR). There were no injuries or deaths reported as a result of any of the complaints.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product: GlideScope Core One TouchSmart Cable (“OneTouch cable”)
Product Codes and Lot Numbers: CCW and Verathon, Inc. part number 0800‐0601
Model or Catalog Numbers: Verathon, Inc. part number 0800‐0601
Manufacturing Dates: September 17, 2019 to April 22, 2020
Distribution Dates: January 17, 2020 to April 22, 2020
Devices Recalled in the U.S.: 356
Date Initiated by Firm: May 6, 2020
The GlideScope Core Video Laryngoscopy System is intended to provide a clear view of the airway and vocal cords for medical procedures. The Core OneTouch Smart Cable is a part of the system and is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors.
