The Medtronic Bravo CF Capsule is a medical device used during esophageal pH monitoring procedures to help diagnose gastroesophageal reflux disease (GERD) and related conditions. The capsule is designed to temporarily attach to the lining of the esophagus and record pH data over time, delivered through a specialized delivery system intended to properly place and secure it.
The recall
In 2025, Medtronic and Given Imaging issued a recall involving certain lots of the Bravo CF Capsule Delivery Device after reports that some capsules failed to properly attach to the patient’s esophagus or detached from the delivery device during placement. According to the FDA, the issue was linked to improper application of adhesive during manufacturing, which may prevent the capsule from functioning as intended. The FDA identified this as a serious recall due to the potential for significant patient injury and complications.
Injuries involved in these claims
Patients who underwent a procedure involving the Bravo CF Capsule and suffered aspiration or inhalation of the capsule, esophageal perforation, airway obstruction, hemorrhage or blood loss, laceration of the esophagus, delayed diagnosis or treatment, foreign objects remaining in the body, or sepsis or infection may have a claim.
Talk to us, at no cost
If you or a loved one was injured during or after a Bravo CF Capsule procedure, Pisanchyn Law Firm offers a free, confidential case review, and we do not charge a fee unless we win. Call 1-800-444-5309. This page is part of our mass tort litigation practice.
Frequently Asked Questions
Why was the Bravo CF Capsule recalled? The FDA linked the recall to improper adhesive application during manufacturing, which could cause capsules to fail to attach properly or detach during placement.
What injuries are involved in these claims? Aspiration of the capsule, esophageal perforation or laceration, airway obstruction, bleeding, retained foreign objects, infection or sepsis, and harm from delayed diagnosis.
How do I know if my procedure used a recalled device? Your procedure records will identify the device and lot, and obtaining those records is part of the case evaluation process.
This page is for general informational purposes and does not constitute legal or medical advice. Reading it does not create an attorney-client relationship.
