Class I Recall: Medtronic Bravo CF Esophageal pH Capsule Delivery Devices
The US FDA has classed the recall of certain Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule delivery devices as the most serious type of recall. The devices are being removed from where they are used or sold.
According to Medtronic, the capsule may fail to attach to the esophagus or fail to detach from the delivery device, due to a problem with the component that controls deployment. Reported risks include aspiration, esophageal perforation or laceration, airway obstruction, bleeding, retained foreign bodies and delayed diagnosis. Some affected lots were part of an earlier recall in June 2025.
The recall covers the 5-pack (FGS-0635) and 1-pack (FGS-0636) delivery devices with expiry dates up to and including 20 October 2027. Lots expiring on 10 December 2027 or later are not included.
Key points
- FDA Class I recall, the most serious category.
- Products: Bravo CF capsule delivery device, 5-pack (FGS-0635) and 1-pack (FGS-0636).
- Affected lots expire on or before 20 October 2027.
- Do not use affected devices; quarantine them and return them to Medtronic for replacement.
- Keeping the delivery device straight, as the user guide instructs, matters because bending can worsen the deployment problem.
What it means for you
Gastroenterology units that perform esophageal pH studies should check their stock of Bravo CF delivery devices against the affected lots. Check with DRAP and your supplier about whether these lots were distributed in Pakistan.
Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.