WASHINGTON, DC — Medtronic has recalled a pH monitoring capsule used to evaluate gastroesophageal reflux after federal regulators linked the device to 184 serious injuries. The Food and Drug Administration said Thursday that the Bravo CF capsules can fail to attach to the esophagus or detach from the delivery device as intended, creating risks that include perforation, airway obstruction and blood loss.
The FDA issued the warning in an early alert notice and said no deaths have been reported. Medtronic had already pulled back a subset of the affected Bravo CF lots last year, but the agency said the two recalls stem from the same failures even though the underlying causes differ.
How the Bravo system is used in reflux diagnosis
Doctors use the Bravo system to place a pH monitoring capsule in the esophagus, where it records acidity levels over time. That data helps physicians diagnose clinical gastroesophageal reflux disease, a condition commonly shortened to GERD.
Medtronic sells the device through its Given Imaging subsidiary. The company acquired Given Imaging as part of the 2014 purchase of Covidien for about $860 million, bringing the Bravo line into its broader medical device portfolio.
Because the capsule is intended to stay attached temporarily and then release, proper deployment is critical. If that process does not work as designed, the device can remain stuck, fail to function correctly or create a foreign body hazard inside the patient.
What can go wrong when the capsule fails to deploy
According to Medtronic and the FDA, the affected Bravo CF capsules may not attach to the patient’s esophagus or may fail to detach from the delivery device. The company said the problem may involve a component that controls capsule deployment.
Medtronic also said the risk may increase if a healthcare professional does not keep the delivery device straight, as the user guide instructs. When deployment fails, the FDA said possible harms include laceration of the esophagus, delayed diagnosis and a foreign body left inside the patient.
Those hazards make the issue more than a simple malfunction. Even when the capsule does not cause immediate trauma, a failed placement can disrupt the monitoring process and force clinicians to deal with a device that is not where it should be.
184 serious injuries reported and no deaths so far
As of Aug. 10, Medtronic had received reports of 184 serious injuries tied to the problem, according to the FDA. Regulators said the current recall covers the same kind of attachment and detachment failures that prompted the previous action, but the root cause is different.
The earlier recall, issued in June 2025, involved 33 reports of serious injury. In that case, Medtronic said the issue came from adhesive being misapplied during manufacturing of the delivery device, not from the deployment component involved in the newer recall.
The distinction matters because it suggests more than one defect path can produce the same patient risk. That makes the recall broader in practical terms, even though the technical explanations differ.
What Medtronic is telling customers to do now
Medtronic wrote to customers earlier this month about the latest recall and instructed them to identify, quarantine and return all unused affected devices. The company said the action is meant to keep the recalled capsules out of use while the issue is addressed.
Not every Bravo CF lot is included. Medtronic said lots with an expiration date on or after Dec. 10, 2027, are not affected by the recall.
For hospitals and clinics that use the system, the immediate task is inventory review. Facilities must separate impacted products, stop them from being used and follow the return instructions provided by the company.
Why the recall matters for hospitals using esophageal pH testing
The Bravo system is used when physicians need direct pH data from the esophagus to evaluate reflux symptoms and related conditions. If the capsule cannot be deployed properly, the test may be delayed, repeated or abandoned, which can affect patient care.
The FDA’s alert underscores how device malfunctions can ripple through routine diagnostics. A failure that begins as a deployment problem can quickly become a patient-safety concern if it causes injury, leaves material behind or prevents a diagnosis from being completed.
Medtronic has not reported deaths linked to the recall, but the serious-injury tally shows that the issue has affected a significant number of patients. The recall also follows a separate action from last year, suggesting the Bravo line remains under close scrutiny.
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