Field Safety Notice Medtronic Bravo™ CF Capsule Delivery Device FAL19842 (ICN 3455)

NHSSC: 48

Alert:

• Medtronic has issued Field Safety Notice recalling specific lots of the Bravo™ CF capsule delivery device.
• Medtronic has identified an increase in complaints involving the Bravo™ CF capsule delivery device where the capsule fails to attach to the esophagus or detach from the delivery device.
• Risks associated with this issue include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
• Please note that a subset of these lots was previously included in a recall notification June 2025. While the issue experienced by customers is the same as that described in the prior recall notification, the underlying cause is different, and this is a separate recall.

Products Affected:

• Two product codes are affected.
• One product code is available via NHS Supply Chain’s eDirect Service:

• Please note only the Lot numbers and expiration dates quoted above and in the Field Safety Notice are affected.
• Medtronic has implemented corrective actions and Lots with an expiration date of 10 December 2027 or later are not affected.
• The supplier is actively managing the recovery of supply and expects unaffected stock to be available within the next two weeks.
• Medtronic will be allocating available stock as fairly as possible to support customers with scheduled procedures, and further deliveries into their facilities are expected regularly.
• NHS Supply Chain is closely working with the supplier to minimise disruption to supply and patient care.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected Lot numbers.
• Complete the Customer Acknowledgement Form, page 4 of the Field Safety Notice, and email to: fsnuki@medtronic.com. On receipt of the completed form Medtronic will arrange to collect the affected products.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products for return to Medtronic, including National Product Code (NPC), Lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and raise your credit as appropriate.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.