OFFICIAL-SOURCE RECALL · AUSTRALIA
Bravo CF capsule delivery device, 5-pk Recall: Classification Class I Reason for the Action
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Bravo CF capsule delivery device, 5-pk
- Manufacturer
- See official notice
- Date code
- dates, dates prior to and including Oc
- Expiration date
- dates, dates prior to and including Oc
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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,
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,
Official recall notice
Bravo CF capsule delivery device, 5-pk
Agency: Therapeutic Goods Administration
Official publication date: August 6, 2026
Read the official AU_TGA_DRAC recall notice →SCAN ONCE. KEEP WATCHING.
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