CanadaThe Bravo — Capsule Delivery System (model/catalogue FGS-0635) is affected; affected units are identified by lot or serial numbers consisting of more than 10 numbers, and lots with an expiration date of December 10, 2027 or later are not in scope. It was recalled because the capsule can fail to attach to the esophagus or detach from the delivery device, which can lead to risks including aspiration/inhalation, esophageal perforation, airway obstruction, hemorrhage, laceration, delayed diagnosis, and retained foreign bodies. Contact the manufacturer for additional information.
What's being recalled
Companies: Given Imaging, Inc., 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048.
How to identify it
Affected products: Bravo - Capsule Delivery Sys; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: FGS-0635
The hazard
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.
Lots with an expiration date of December 10, 2027, or later are not in scope of this recall and do not need to be returned.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)