FDA Issues Alert on Medtronic Esophageal pH Monitoring Device Due to Delivery Issues

The FDA has issued an Early Alert regarding a delivery device issue with specific esophageal pH monitoring capsules from Medtronic and Given Imaging, Inc. Medtronic has advised customers to remove affected devices from use or sale. This alert updates a June 2025 recall, noting 184 serious injuries reported as of August 10, 2026, though no fatalities have occurred.