Medical device manufacturer, Given Imaging, has issued a field safety notice on Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles).
The manufacturer has received reports of failure of the Bravo capsule to attach to the esophagus or failure of the capsule to detach from the placement device. Occurrence of these failures may result in lengthened time for a Bravo procedure, esophageal injury, and/or the need for additional procedures.
Upon investigations, the manufacturer determined that these failures have a combination of root causes including issues related to tolerances in certain manufacturing dimensions. The manufacturer will replace the affected devices. An "Attention" label on how to perform the rescue procedure and an updated User Manual are now being provided with all Bravo devices.
According to the local supplier, the affected product has been distributed in Hong Kong. If you are in possession of the product, please contact your supplier for necessary actions.