A device swallowed by patients during one of the most common tests for chronic heartburn is now the subject of a federal safety alert, after the manufacturer reported 184 serious injuries linked to the same failure. The Food and Drug Administration issued the alert on August 27, covering Medtronic and Given Imaging's Bravo CF capsule delivery devices in one-pack and five-pack configurations.
The failure is straightforward to describe and difficult to experience. The capsule may fail to attach to the esophageal wall or to detach from the delivery device as intended. When that happens, the risks the FDA lists are not limited to a wasted test; they include aspiration or inhalation of the capsule, perforation of the esophagus, obstruction of the airway, bleeding, laceration of the esophagus, delayed diagnosis, and foreign bodies remaining in the patient.
