The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.
The Food and Drug Administration (FDA) issued an early alert regarding a potentially high-risk issue with certain esophageal pH monitoring capsule delivery devices manufactured by Medtronic and its subsidiary, Given Imaging.
The alert involves the Bravo CF capsule delivery device in one-pack and five-pack configurations. All affected lots have expiration dates on or before Oct 20, 2027. Medtronic and Given Imaging have recommended that customers remove these devices from where they are used or sold.
As of August 10, 2026, Medtronic has reported 184 serious injuries and no deaths associated with the issue. Risks linked to the device failure include patient aspiration, perforation of the esophagus, obstruction of the airway, bleeding, and foreign bodies remaining in the patient.
According to the alert, the Bravo CF capsule may fail to attach to the patient’s esophagus or fail to detach from the delivery device as intended. These failures may be due to a problem with the component that controls the deployment of the capsule. The company noted that the deployment control problem can be exacerbated by a failure to keep the delivery device straight during use.
A subset of the affected lots was previously included in a recall notification sent to customers in June 2025. Although the failure experienced by customers in this alert is the same as described in the prior recall, the underlying cause is different, according to the FDA.
Recommendations for Healthcare Facilities
Medtronic sent a letter to all affected customers on Aug 6, 2026, recommending that they immediately identify and quarantine all unused affected devices. Healthcare providers are instructed to return all unused, affected products to Medtronic for replacement.
Lots with an expiration date of Dec 10, 2027, or later are not in the scope of this action and do not need to be returned.
The Bravo system is designed to place a monitoring capsule in the esophagus to record pH data, helping physicians diagnose clinical gastroesophageal reflux. The system uses a capsule placed against the mucosal wall of the esophagus that transmits data to a recorder worn by the patient.
The FDA is currently reviewing information about the issue and will update the public as significant new information becomes available.
