Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades: Class I Recall - Risk of Blade Tip Breakage and Premature Failure
AUDIENCE: Risk Manager
ISSUE: GlideScope GVL and AVL reusable blades were recalled due to the potential risk of breakage and premature failure of the blade tip. Device failure may not be readily visible during routine inspection before or after insertion of the laryngoscope. This could result in pieces of the blade breaking off in patients’ mouths and being swallowed or blocking the airway. This product may cause serious adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to the airway leading to a significant loss of blood, and/or death.
BACKGROUND: The GlideScope Video Laryngoscope (GVL) and GlideScope Advanced Video Laryngoscope (AVL) are used by qualified medical professionals to obtain a clear, open view of the vocal cords for medical procedures.
RECOMMENDATION: On May 10, 2013, Verathon sent “Urgent Medical Devices Recall” letters to all affected customers. The letter identified the problem, affected product, and actions to be taken. Customers were advised to:
- Stop using affected devices
- Return affected devices to Verathon for replacement
- Complete the “Return Response” form
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.htm
- 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
[07/10/2013 - Recall Notice - FDA]