Official recall record
Bravo - Capsule Delivery System
- Issuing authority
- Health Canada
- Alert date
- 2026-08-07
- Country of alert
- Canada
- Alert level
- Type I
- Alert type
- recall
What the authority reported
Medtronic has identified an increase in complaints involving the Bravo CF capsule delivery device where the capsule fails to attach to the esophagus or detach from the delivery device. Medtronic's preliminary root cause investigation has identified a potential condition impacting the component that controls the deployment of the capsule which can then be exacerbated by a failure to keep the delivery device straight as instructed in the user guide, as a potential cause. Risks associated with this issue 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. Lots with an expiration date of December 10, 2027, or later are not in scope of this recall and do not need to be returned.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-08-17.