Medtronic and its subsidiary Given Imaging have recalled certain Bravo CF capsule delivery devices after Medtronic reported 184 serious injuries associated with the issue as of Aug. 10.
Medtronic said the Bravo CF capsule may fail to attach to a patient’s esophagus or fail to detach from the delivery device as intended, according to an Aug. 31 FDA news release. The failures may result from a problem with the component controlling the capsule’s deployment. Potential risks include aspiration or inhalation, esophageal perforation, airway obstruction, bleeding, esophageal laceration, delayed diagnosis and a foreign body remaining in the patient.
Medtronic sent affected customers a letter Aug. 6 instructing them to immediately identify and quarantine unused affected devices and return them for replacement. The affected products include the Bravo CF capsule delivery device 5-pack (FGS-0635) and 1-pack (FGS-0636). All affected lot numbers have expiration dates on or before Oct. 20, 2027.
A subset of affected lots was previously included in a June 2025 recall notification.
