Medical device maker Verathon Inc. recalled certain lots of its reusable laryngoscope blades after finding that they may be prone to cracks and breaks that may leave pieces in a patients mouth where they may be swallowed or block the airway.
The blades in question belong to the company’s GlideScope GVL video laryngoscopes, designed to provide a "consistently clear, real-time view of the patient’s airway, enabling quick intubation," according to the company’s website.
There have been not reports of patient injury associated with the blades, but Verathon noted that the device components may be prone to developing "stress cracks" that may not be readily visible during a routine inspection prior to patient use.
"This cracking may eventually cause the blade tip to break and the product to fail," according to an FDA notice. "The firm voluntarily recalled the products after learning about design characteristics leading to cracked and broken blades."
The GlideScope GVL system includes a high-resolution camera, anti-fogging mechanisms to provide clearer views, a color monitor and proprietary blade angulation, according to the company. The device helps physicians place breathing tubes, promising to require less force than traditional direct placement methods.
The recall affects 3 lots of the GlideScope GVL devices, which were manufactured between December 2010 and August 2011, according to the FDA report. Verathon is asking customers to arrange for a return and replacement of all affected products.
The lots in question are:
- GlideScope GVL 3, 0574-0007: MD10500 to MD112387
- GlideScope GVL 4, 0574-0001: LG105000 to LG112758
- GlideScope GVL 5, 0574-0030: XL105000 to XL111798