FDA announces Class 1 recalls for laryngoscopes, ventilators

Editor's Note

Recalls of certain devices and instruction updates for others prompted the US Food and Drug Administration (FDA) to issue Class 1 recalls—the most severe category indicating risk of serious injury or death—for two groups of products: Medtronic’s McGrath MAC and MAC EMS Video Laryngoscopes and Breas Medical’s Vivo 45 LS ventilator.

In the case of the laryngoscopes, which are used to see into the trachea during medical procedures, the Medtronic recall was driven by concerns about battery depletion, according to FDA’s September 5 announcement. The resulting instability, increased temperature, and potential battery explosion put patients at risk of burns, lacerations, and other injuries.

One injury and no deaths have been reported so far. The full report offers further details about recommended actions for specific models, some of which are being removed and some of which have updated instructions. 

Breas Medical is updating use instructions for Vivo 45 LS ventilators after internal testing identified potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time. According to FDA’s September 5 announcement, risks include temporary, reversible airway irritation or inflammation leading to airway issues such as asthma, and death, especially in small pediatric patients. No injuries or deaths have been reported so far. 

In a third September 5 announcement, FDA designated Abbott Diabetes Care Inc’s recall of The FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System, as Class 1. According to the report, a small number of these sensors may provide incorrect high glucose readings, which could lead to hypoglycemia and subsequent seizure, coma, brain damage or death. No deaths and 2 injuries have been reported.