Health Canada7 Aug 2026
Bravo - Capsule Delivery System
Health Canada published a recall notice for Bravo - Capsule Delivery System on 7 Aug 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 7 Aug 2026
- Recall type
- Health product recall
- Companies
- Given Imaging, Inc.15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. Additional information Details Original published date: 2026-08-07 Affected products: Affected products Lot or serial number Model or catalogue number Bravo - Capsule Delivery Sys More than 10 numbers, contact manufacturer. FGS-0635 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.