Medtronic is recalling certain esophageal pH monitoring capsule delivery devices amid the risk of them failing whilst deployed.
The medtech giant sent a letter to customers on August 6, and the FDA is now following up with an early alert.
The alert centers on Medtronic’s Bravo CF (Calibration-Free) capsule that works as a wireless device used to measure and monitor stomach acid levels in the esophagus.
The device is attached to the wall of the esophagus during an endoscopy and then monitors reflux levels wirelessly for several days before naturally detaching and later passing through the digestive system.
The issue Medtronic found is that the CF capsule “may not attach to the patient’s esophagus or detach from the delivery device as intended,” the FDA said in its alert.
These problems could be down to an issue with the component that controls the deployment of the capsule. Medtronic also said this could be made worse “by a failure to keep the delivery device straight as instructed in the User Guide.”
The issue can potentially cause hemorrhaging, obstruction of airways and lacerations, among other possible risks.
As of August 10, Medtronic had reported 184 serious injuries and no deaths associated with the issue.
A subset of lots have previously been affected by this issue and were included in a recall notification from June 2025.
“The failure experienced by customers in this recall is the same as described in the prior recall, but the underlying cause is different,” the company said, as reported by the FDA in its alert.