Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging

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. Affected Product The FDA is aware that Medtronic and their subsidiary Given Imaging, Inc.

have issued a letter to affected customers recommending certain esophageal pH monitoring capsule delivery devices be removed from where they are used or sold.Affected devices:Product NameProduct NumberUDI-DIBravo CF capsule delivery device, 5-pkFGS-063507290101369707Bravo CF capsule delivery device, 1-pkFGS-063607290101369714All affected lot numbers have expiration dates prior to and including October 20, 2027.Full List of Affected Lot NumbersWhat to DoDo not use affected delivery devices. Immediately identify and quarantine affected devices until they can be returned to Medtronic for replacement.On August 6, 2026, Medtronic sent all affected customers a letter recommending the following actions:Immediately identify and quarantine all unused affected devices.Return all unused, affected products to Medtronic for replacement.Pass this information on to all those who need to be aware within your organization or to any organization where the affected product has been transferred or distributed.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.Use the example product label (pictured below) to help identify the lot number and expiration date on Bravo CF capsule delivery devices. Check this web page for updates.

The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for AlertMedtronic 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.Device UseThe Bravo system is designed to place and attach a pH monitoring capsule to the esophagus that records pH data to assist a physician in diagnosing clinical gastroesophageal reflux. The Bravo system involves the placement of a pH capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a recorder attached to the patient’s waist. The patient interacts with the recorder to indicate symptoms, allowing the physician to compare the patients’ symptoms to the occurrence of the reflux episodes.Contact InformationCustomers in the U.S.

with adverse reactions, quality problems, or questions about this issue should contact Medtronic at 800-448-3644, Option 3.Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.