Bravo - Capsule Delivery System

Issue

Medtronic has identified an increase in complaints involving the Bravo CF capsule delivery device where the capsule fails to attach to the esophagus or detach from the delivery device. Medtronic's preliminary root cause investigation has identified a potential condition impacting the component that controls the deployment of the capsule which can then be exacerbated by a failure to keep the delivery device straight as instructed in the user guide, as a potential cause. Risks associated with this issue include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient. Lots with an expiration date of December 10, 2027, or later are not in scope of this recall and do not need to be returned.