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# Safety Alert on Medtronic Esophagus pH Monitor
- URL: https://www.fdaweb.com/safety-alert-on-medtronic-esophagus-ph-monitor/
- Published: 2025-06-24T12:00:00.000Z
- Updated: 2026-09-14T15:15:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159409

FDA has issued a [safety alert](https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-esophageal-ph-monitoring-capsule-issue-medtronic?utm%5Fmedium=email&utm%5Fsource=govdelivery) on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to place and attach a pH monitoring capsule to the esophagus to assist a physician in diagnosing clinical gastroesophageal reflux.

The alert says Medtronic has told customers that the capsule may not attach to the patient’s esophagus or detach from the delivery device as intended due to a misapplication of adhesive during the devices’ manufacturing. “Risks associated with this issue include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient,” the alert says.

To date, Medtronic has reported 33 serious injuries and no deaths associated with the issue.