Given Imaging Ltd. recalls Bravo CF capsule delivery device

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks 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.

On August 10, 2026, the firm notified consignees via "URGENT: MEDICAL DEVICE RECALL" letters. Please note this is a separate recall from that initiated in June 2025, which involved the same issue, but a different underlying cause. Customers were instructed to do the following: 1. Immediately identify and quarantine all unused and affected devices. 2. Return all product to Medtronic for replacement as described in the letter. 3. Complete and return the included customer response form to the firm via email: rs.gmbmitgfca@medtronic.com, even if you do not have unused affected inventory. 4. Notify all those who need to be aware within your organization, or those to whom affected product was transferred/distributed. 5. Maintain a copy of the recall letter for your records. If you have any questions regarding this communication, please contact your local Medtronic Representative or call 720-774-3454.

• FDA enforcement recordOfficial FDA database entry for Z-3090-2026
• FDA device classification · FFTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Given Imaging Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.