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Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
The FDA is aware that Medtronic and their subsidiary Given Imaging, Inc. have issued a letter to affected customers recommending certain Bravo CF capsule delivery devices be removed from where they are used or sold.
Medtronic stated that the Bravo CF capsule may not attach to the patient’s esophagus or 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. Medtronic stated that the deployment control problem can be exacerbated by a failure to keep the delivery device straight as instructed in the User Guide.
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.
Medtronic stated that a subset of lots affected by this issue were previously included in a recall notification sent to customers and distributors in June 2025. The failure experienced by customers in this recall is the same as described in the prior recall, but the underlying cause is different.
As of August 10, 2026, Medtronic has reported 184 serious injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medtronic at 800-448-3644, Option 3.
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