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TGA Action ID	RC-2026-RN-00591-1
Type of Product	Medical Device
Product Name/Description	Bravo CF capsule delivery device, 5-pk Product Number: FGS-0635 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)
ARTG Number	205795
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class I
Reason for the Action	Medtronic has identified an increase in complaints involving the Bravo CF capsule delivery device where the capsule fails to attach to the oesophagus 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 oesophagus, obstruction of the airway, haemorrhage/blood loss/bleeding, laceration of the oesophagus, a delay in diagnosis, and foreign bodies remaining in the patient. From January 1, 2025 – July 7, 2026, Medtronic has received 761 complaints globally for failure to attach or failure to detach, of which 184 included a patient outcome of serious injury. No deaths have been reported.
Instructions for Customers/Users	Customers are to immediately identify and quarantine all unused and affected devices. Return all unused, affected product(s) to Medtronic for credit as described on the Customer Response Form.
Action Commencement Date	6/08/2026
Responsible Entity	Medtronic Australasia Pty Ltd
Contact Information	0421 275 044 - Simon Turner