FDA Warns About Medtronic Reflux-Monitoring Device

The Food and Drug Administration is warning healthcare providers about a potentially high-risk problem involving certain Medtronic reflux-monitoring devices.

The alert covers affected lots of Bravo C-F capsule delivery devices used to attach a p-H monitoring capsule to a patient’s esophagus.

Medtronic says the capsule may fail to attach properly or may not detach from the delivery device as intended. Potential complications include aspiration, an obstructed airway, esophageal injury or bleeding.

The company has reported 184 serious injuries and no deaths connected to the issue.

Providers should stop using affected devices, quarantine them and return unused products to Medtronic for replacement. The alert covers certain lots with expiration dates through October 20th, 2027. U.S. Food and Drug Administration