The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling a group of Bravo CF capsules used to monitor esophageal pH after the company received reports of 184 serious injuries associated with a defect that may prevent the capsule from attaching to the esophagus or detaching from the delivery device as intended. No deaths associated with the issue had been reported through August 10, 2026, according to information in the agency’s early notification.
The Bravo system is used to attach a capsule to the esophagus and record acidity data, helping physicians clinically diagnose gastroesophageal reflux disease. Medtronic sells the system through its subsidiary Given Imaging, the company that Covidien—which is currently part of Medtronic—acquired in 2014 for approximately $860 million.
What Is Wrong With the Capsules?
The recalled capsules may fail to attach to the patient’s esophagus, or they may not detach from the delivery device when needed. According to Medtronic, the problem is caused by a defect in the component responsible for deploying the capsule. The likelihood of failure may increase if the healthcare professional does not keep the delivery device straight, as specified in the instructions for use.
The risks are not limited to measurement failure; the failure may result in a tear or injury to the esophagus, delayed diagnosis, or a retained foreign body inside the patient. The FDA also listed esophageal perforation, airway obstruction, and blood loss among the potential risks.
Recurring Recall, but for a Different Reason
This recall marks the second time in two years that Medtronic has withdrawn Bravo capsules from the market because of the same failure pattern. In June 2025, the company recalled Bravo devices after 33 serious injuries were reported in connection with the capsule failing to attach or detach from the delivery device.
However, the FDA explained that the underlying cause differs between the two recalls. In the 2025 case, the defect was associated with improper application of adhesive during manufacture of the delivery device, whereas the current recall is associated with a problem in the capsule-deployment component.
What Are Healthcare Facilities Required to Do?
Medtronic informed customers earlier this month that they must identify affected, unused devices, quarantine them, and return them to the company. Devices bearing expiration dates of December 10, 2027, or later are not included in the recall, according to the published information.
Why Does This News Matter?
The importance of the recall lies in the combination of a recurring clinical outcome—the failure of attachment or detachment—and a different manufacturing cause this time, along with the higher number of reported serious injuries compared with the previous recall. In practice, facilities using the system need to verify lot numbers and expiration dates before using any device, while details about the affected lots and how to manage patients in whom these capsules were used remain matters that require consultation of the company’s and regulator’s notices.