U.S. healthcare authorities put their highest-risk stamp on a recall by Verathon Inc., judging that the crack-prone blades in Verathon’s GlideScope GVL video laryngoscopes represent a risk to patients.
Veathon late last year recalled certain lots of its reusable laryngoscope blades after finding that they may be prone to cracks and breaks that could harm patients if left in the mouth or throat.
"This could result in pieces of the blade breaking off in patients’ mouths and being swallowed or blocking the airway," according to the new FDA notice. " 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."
Verathon in December recalled the the blades, noting that no patients had been reported harmed. The company in May issued an "Urgent Medical Devices Recall" to its customers, warning of the risk to patients. Healthcare providers were warned to stop using the affected devices and return them to Verathon for replacement.
