Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (OneTouch cable), Due to Partial or Complete Loss of Image During Use
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.
Wed Jul 22 2020
- GlideScope® Core One™ TouchSmart Cable (“OneTouch cable”)
- Product Codes and Lot Numbers: CCW and Verathon, Inc. part number 08000601
- Model or Catalog Numbers: Verathon, Inc. part number 08000601
- 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.
Reason for Recall
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.
Who May be Affected
- Health care providers using affected device
- Patients undergoing procedures using the affected device
What to Do
On June 5, 2020, Verathon Inc. sent a Field Safety Notice to affected customers informing them of the issue and provided the following instructions:
- Review the information contained within this Field Safety Notice with all staff members who should be aware of the contents of the Field Safety Notice.
- Locate all Core OneTouch Smart Cables in the facility.
- Discontinue use of all Core OneTouch Smart Cable(s).
- Be aware that Core Smart Cable, QuickConnect Cable, and Core Video Cable can continue to be used with GlideScope products and do not require additional inspection.
- When replacements are received, destroy or return all Core One Touch Smart Cables.
- Complete the Recall Response Form (last page of the Field Safety Notice):
- Answer all four (4) questions by checking the appropriate box.
- List the OneTouch Smart Cables in possession, one serial number per cell (The serial number starts with SG and can be found on top of the magnetic connector)
- Verify and complete the Customer Information.
- Sign, date, and return the Recall Response Form to Verathon by email to CSNotifications@verathon.com to make arrangements for return and replacement of your Core OneTouch Smart Cable.
Customers who have questions about this recall can contact Verathon’s Customer Care Agent by phone at (800) 331-2313, Monday through Friday between 6:00am and 4:00pm (Pacific Time) or by emailing CSNotifications@verathon.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.