Bravo Capsule Delivery System Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Health Canada recalls Bravo Capsule Delivery System due to risks of capsule failing to attach or detach properly, potentially causing serious complications.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on August 7, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.
What Happened
Medtronic identified an increase in complaints with the Bravo CF capsule delivery device where the capsule fails to attach to the esophagus or detach from the delivery device. The preliminary root cause involves a potential condition impacting the component that controls capsule deployment, which can be worsened by failing to keep the delivery device straight as instructed.
Which Products Are Affected
- Product: Bravo - Capsule Delivery Sys
- Model/catalogue number: FGS-0635
- More than 10 lot or serial numbers affected; contact manufacturer for details
- Lots with an expiration date of December 10, 2027, or later are not included in this recall
What You Should Do
Consumers and healthcare providers should contact the manufacturer for information on affected lots and returns. Affected units should be returned as directed.
Why This Matters
Risks include patient aspiration/inhalation, perforation of the esophagus, airway obstruction, hemorrhage, laceration of the esophagus, delayed diagnosis, and foreign bodies remaining in the patient.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,186 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.