Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades
Recall Class: Class I
Date Recall Initiated: 05/08/2013
Product(s): GlideScope Video Laryngoscope GVL and AVL Reusable Blades
Model, Part and Serial Numbers:
To locate the model, part and serial numbers of affected products, refer to FDA’s Class I Recall information under "Additional Links" below.
These products were manufactured and distributed from August 01, 2011 to June 30, 2012.
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.
20001 N Creek Pkwy
Bothell, Washington 98011
Reason for Recall:
The 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.
Customers with questions are directed to contact Verathon Customer Care at 800-331-2313 (US and Canada) (Mon. - Fri., 6 am to 5pm PST) and 1-425-867-1348 (Mon. - Fri., 6 am to 4:30pm PST) for those customers outside of the US and Canada. Alternately, customers can e-mail Verathon at firstname.lastname@example.org.
FDA District: Seattle District Office
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 do the following:
- Stop using affected devices
- Return affected devices to Verathon for replacement
- Complete the "Return Response" form
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.