| TGA Action ID |
RC-2025-RN-00526-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Bravo CF capsule delivery device
Bravo CF capsule delivery device, 5-pk
Product Number: FGS-0635
Bravo CF capsule delivery device, 1-pk
Product Number: FGS-0636
Multiple lot numbers |
| ARTG Number |
205795 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient’s oesophagus or detaching from the delivery device.
Malfunction of the Bravo CF capsule delivery device could result in the following harms: aspiration/inhalation, perforation of oesophagus, airway obstruction, haemorrhage/blood loss/bleeding, laceration of oesophagus, delay to diagnosis, additional device required, and foreign body in patient.
An increase in the number of serious injuries during use of the Bravo CF capsule delivery has been reported during January 2025 – April 2025. The increased number of serious injuries may be attributed to the device’s malfunction due to misapplied adhesive. |
| Instructions for Customers/Users |
Customers are to:
•Immediately identify and quarantine all unused FGS-0635 (Bravo CF capsule delivery device, 5-pk) and FGS-0636 (Bravo CF capsule delivery device, 1-pk).
•Return all unused, affected product(s) to Medtronic.
This action has been closed out on 18/08/2026 |
| Action Commencement Date |
3/06/2025 |
| Responsible Entity |
|
| Contact Information |
0421 275 044 - simon.turner@medtronic.com- Simon Turner |