Medtronic Recalls Bravo CF Capsule Delivery Devices After 184 Serious Injuries, Reviving A Prior Failure Mode

Medtronic is recalling certain esophageal pH monitoring capsule delivery devices tied to its Bravo CF (Calibration-Free) capsule, a wireless device used to measure and monitor stomach acid levels in the esophagus.

The FDA said the problem is that the CF capsule “may not attach to the patient’s esophagus or detach from the delivery device as intended.” Medtronic sent a letter to customers on August 6, and the FDA later followed with an early alert. As of August 10, Medtronic had reported 184 serious injuries and no deaths associated with the issue.

The Device Problem

The Bravo CF capsule is attached to the wall of the esophagus during an endoscopy, then monitors reflux levels wirelessly for several days before naturally detaching and later passing through the digestive system.

According to the FDA, the attachment and detachment failures could stem from a problem with the component that controls capsule deployment. Medtronic also said the issue could be made worse “by a failure to keep the delivery device straight as instructed in the User Guide.” The potential risks include hemorrhaging, obstruction of airways and lacerations.

Why This Matters

A subset of lots had previously been affected by a related issue and were included in a recall notification from June 2025. The company said, as reported by the FDA, that the failure seen in the current recall is the same as described in the prior recall, but that the underlying cause is different.

That distinction is the key signal for device operators and buyers: Medtronic is dealing not just with an isolated lot problem, but with another episode affecting the same product’s deployment performance. Even without reported deaths, 184 serious injuries is a large count for a monitoring device, and it raises the operational stakes for endoscopy centers that rely on the system.