FDA Alerts Public to Issue with Esophageal pH Monitoring Devices

The FDA has issued an early alert regarding certain esophageal pH monitoring capsule delivery devices from Medtronic and its subsidiary Given Imaging, Inc. Medtronic has advised customers to remove affected devices from use or sale due to an identified issue. As of August 10, 2026, 184 serious injuries have been reported in connection with this problem, though no fatalities have occurred.