The FDA has escalated a Class I recall of Medtronic’s Bravo reflux testing system after 33 reports of serious injuries linked to the device. The Bravo system, commonly used to diagnose GERD, involves placing a pH-sensing capsule in the esophagus to detect acid levels. However, a manufacturing defect—specifically, misapplied adhesive—may cause the capsule to dislodge from the delivery system or fail to attach properly to the esophageal wall.
The result? Risk of airway obstruction, tissue perforation, and internal bleeding. While no deaths have been reported, Medtronic and its Given Imaging unit have urged providers to quarantine affected lots and return them. The FDA, as part of its new rapid-alert pilot, labeled the issue high risk.