FDA Expands Recall of Medtronic Bravo CF Capsule Delivery Devices
The FDA has expanded its ongoing recall of Medtronic Bravo CF capsule delivery devices, adding new lot codes and urging users to quarantine and return affected devices.
4 reports on this incident · first at Aug 28, 2026, 7:01 a.m. ET
Earlier reports
Aug 28, 2026, 7:11 a.m. ET
FDA Reports 184 Injuries in Ongoing Medtronic Bravo CF Capsule Recall
The U.S. Food and Drug Administration (FDA) has reported 184 serious injuries and no deaths associated with the use of Medtronic's Bravo CF capsule delivery devices, as of August 10, 2026, according to Medical Daily.
The FDA initiated an ongoing recall on August 6, 2026, for the Bravo CF capsule delivery devices, available in one-pack and five-pack configurations, with identifying codes FGS-0635 and FGS-0636. The agency states the capsule may fail to attach to the esophageal wall or to detach from the delivery device as intended, posing hazards including aspiration or inhalation of the capsule, perforation of the esophagus, obstruction of the airway, bleeding, laceration of the esophagus, delayed diagnosis, and foreign bodies remaining in the patient.
The FDA advises identifying and quarantining all unused affected devices and returning them for replacement.
Aug 28, 2026, 7:07 a.m. ET
FDA Closes Recall of Medtronic Bravo CF Capsule Delivery Devices
The U.S. Food and Drug Administration has closed the recall of Medtronic Bravo CF capsule delivery devices, according to a report from Medical Daily. The closure means the agency considers the recall carried out. The devices, sold in one-pack and five-pack configurations, carry identifying codes FGS-0635 and FGS-0636.
The recall was initiated on August 6, 2026, because the capsule may fail to attach to the esophageal wall or to detach from the delivery device as intended. The FDA reported 184 serious injuries and no deaths as of August 10, 2026. The hazard includes aspiration or inhalation of the capsule, perforation of the esophagus, obstruction of the airway, bleeding, laceration of the esophagus, delayed diagnosis, and foreign bodies remaining in the patient.
The remedy instructed users to identify and quarantine all unused affected devices and return them for replacement. The status of the recall is ongoing.
Aug 28, 2026, 7:01 a.m. ETFirst report
FDA Issues Early Alert for Medtronic Bravo CF Capsule Delivery Devices
The U.S. Food and Drug Administration (FDA) has issued an early alert concerning Medtronic Bravo CF capsule delivery devices, according to a report from Medical Daily. The alert, initiated on August 6, 2026, covers devices in one-pack and five-pack configurations, identified by model codes FGS-0635 and FGS-0636.
The FDA reported that the capsule may fail to attach to the esophageal wall or detach from the delivery device as intended, potentially leading to aspiration or inhalation of the capsule, perforation of the esophagus, airway obstruction, bleeding, laceration of the esophagus, delayed diagnosis, or foreign bodies remaining in the patient. As of August 10, 2026, there have been 184 serious injuries and no deaths reported, according to Medical Daily.
The FDA advises identifying and quarantining all unused affected devices and returning them for replacement. The status of the alert is ongoing.
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