Medtronic and its subsidiary Given Imaging, Inc. have issued an Early Alert concerning their Bravo CF capsule delivery devices, advising customers to remove certain units due to a risk of the capsule failing to attach or detach properly from a patient's esophagus.
The issue stems from a component controlling capsule deployment, which Medtronic said can be worsened if the delivery device is not kept straight as instructed. This malfunction carries significant risks, including patient aspiration, esophageal perforation, airway obstruction, hemorrhage, and delayed diagnosis.
As of August 10, 2026, Medtronic has reported 184 serious injuries linked to this problem, though no deaths have occurred. The FDA's Center for Devices and Radiological Health (CDRH) is issuing this alert to inform the public about this potentially high-risk medical device issue.
This current problem mirrors failures described in a previous recall from June 2025, but Medtronic clarified that the underlying cause for the current alert is distinct. The FDA will continue to update the public as new information becomes available.