The FDA on Thursday warned of 184 serious injuries linked to recalled Bravo calibration-free (CF) acid-monitoring capsule delivery devices, which are used to help diagnose gastroesophageal reflux.
“Medtronic stated that the Bravo CF capsule may not attach to the patient’s esophagus or detach from the delivery device as intended,” according to the FDA. “These failures may be due to a problem with the component that controls the deployment of the capsule.”
Potential risks include aspiration, airway obstruction, laceration or perforation of the esophagus, hemorrhage, and device parts being left inside in the patient. The problem can be made worse if the delivery device isn’t kept straight during the procedure, according to Medtronic.
When working as intended, the Bravo system places a pH monitoring capsule against the mucosal wall of the esophagus in order to record pH data.
The device “simultaneously measures pH and transmits the data to a recorder attached to the patient’s waist,” the FDA explained. “The patient interacts with the recorder to indicate symptoms, allowing the physician to compare the patients’ symptoms to the occurrence of the reflux episodes.”
FDA said that any devices from affected lots should not be used and should instead be quarantined until they can be returned for replacements. Lots expiring Dec. 10, 2027, are not part of the recall from Medtronic and its subsidiary Given Imaging.
A subset of the affected lots of the Bravo CF devices were also included in a recall in June 2025 due to similar issues, but with a different underlying cause. In that case, affected capsules would fail to attach to a patient’s esophagus or fail to detach from the device as intended because adhesive had been misapplied during manufacturing. Medtronic reported 33 serious injuries associated with that problem, and FDA ultimately designated the recall a Class I, its most serious type.
A July 2025 report to FDA’s device safety database described a 28-year-old woman who had a Bravo capsule removed after being hospitalized and experiencing “incredible pain.” It seemed like the device caused the “sloughing off of the entire esophagus,” a doctor is quoting as saying. The patient had not been informed of the recall, according to the report.
