31 Aug Bravo™ CF capsule delivery device, 5-pk & 1-pk
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Medtronic Africa (Pty) Ltd. Waterfall Distribution Campus,
Cnr. K101 & Bridal Veil Road Midrand 1685
|
N/A | As per recall letter | Expiration dates prior to and including
20 October 2027 |
5-pk & 1-pk
|
Not specified
|
Class II Type B | 27 August 2026 |
Brief description of the problem (reason for recall)
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. 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 esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
Advice for health professionals and distributors:
Immediately identify and quarantine all unused and affected devices described above in the product scope.
Return all unused, affected product(s) to Medtronic. Please complete and return the enclosed Customer Acknowledgement Form even if you do not have unused inventory. Pass on this notice to all those who need to be aware within your organization or to any organization where the affected product has been transferred or distributed. Please maintain a copy of this communication in your records.
Additional Information:
Medtronic has notified the Competent Authority of your country of this action.
We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative Nomcebo Mokadi, Senior Regulatory Affairs Specialist at email address: nomcebo.mokadi@medtronic.com.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.