GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall - Potential Video Feed Disruption

AUDIENCE: Risk Manager, Otolaryngology, Anesthesiology

ISSUE: Verathon Incorporated is recalling the GlideScope Titanium Single-Use Video Laryngoscope because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor. A disrupted or unstable video image may lead to delayed tracheal tube insertion, intubation failure and other serious adverse health consequences, including low levels of oxygen in the blood (hypoxemia), end organ damage or death.

See the Recall Notice for a listing of affected model codes and lot numbers.

BACKGROUND: The GlideScope Titanium Single-Use Video Laryngoscope is used to obtain a clear view of the vocal cords and to assist in the insertion of a tracheal tube used during other medical procedures (i.e. general anesthesia).

RECOMMENDATION: On January 29, 2016, Verathon Inc. sent a Customer Recall letter instructing customers to:

Review the list of affected products and lots
Fill out and return the attached Recall Response Form even if the inventory was free of affected products
Return affected products along with the Recall Response Form, or to destroy them and provide evidence of destruction
Contact the firm’s customer care line at 1-800-331-2313 to arrange for delivery of replacement products

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm491340.htm