Medtronic and Given Imaging recall Bravo CF esophageal pH monitoring capsule delivery devices

Medtronic and its subsidiary Given Imaging have issued a recall of the Bravo CF esophageal pH monitoring capsule delivery devices after reports that the capsules may fail to attach or detach from the delivery system.

The FDA classified the recall as Class I, the most serious type, indicating that continued use could cause serious injury or death. The recall covers specific lot numbers with expiration dates up to October 20, 2027.

Customers were instructed on August 6, 2026 to immediately identify, quarantine, and return any unused devices for replacement, and to inform all relevant parties within their organizations.

Devices with expiration dates of December 10, 2027, or later are not included in the recall.