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Health Canada Medical devices

Bravo™ - Capsule Delivery Sys

Issued June 5, 2025
Issue
Medtronic noted an increase in the number and rate of serious injuries during use of the Bravo™ CF Capsule delivery reported between January 2025 and April 2025. The increased number and rate of serious injuries may be attributed to the device's malfunction due to misapplied adhesive. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. Recall start date: June 3, 2025
Hazard description
Performance
Product
Product name
Bravo™ - Capsule Delivery Sys
Reference
ID
RA-77560