The US Food and Drug Administration has issued an Early Alert for Medtronic-owned Given Imaging's Bravo CF esophageal pH monitoring capsule delivery devices, citing potential failure to attach to the esophagus or detach as intended, which could lead to serious complications such as aspiration, esophageal perforation, airway obstruction, hemorrhage, laceration, delayed diagnosis, or retained foreign bodies. Medtronic has reported 184 serious injuries as of August 10, though no deaths have been reported. The company has instructed customers not to use or sell the affected devices.
Medtronic PLCFDA issued an Early Alert for Medtronic's Bravo CF delivery devices after 184 serious injuries, and the company told customers to stop using or selling them.
