A medical test should provide answers, not create new questions. The Bravo capsule is designed to temporarily attach to the esophagus and monitor acid levels before passing naturally through the digestive tract. For some patients, however, the device failed to detach as intended. This device failure has led to severe complications such as inhalation of the capsule, esophageal perforation, airway obstruction, and hemorrhage.
If you or a loved one experienced serious complications after a procedure involving the Medtronic Bravo™ CF capsule delivery device, you may be entitled to compensation.
What is the Medtronic Bravo™ pH capsule?
The Medtronic Bravo capsule is a small, wireless pH-monitoring device used to measure acid levels in the esophagus. It’s approved for use in adults and children ages 4 and older and typically monitors gastroesophageal pH for up to 48 hours. Healthcare providers use the test to help diagnose and evaluate gastroesophageal reflux disease (GERD).
To perform the test, a healthcare provider temporarily attaches the capsule to the lining of the esophagus, where it continuously measures acid exposure. It wirelessly transmits this information to a portable recorder worn by the patient, allowing doctors to determine how often stomach acid flows back into the esophagus. The results help diagnose GERD, assess its severity, and develop an appropriate treatment plan.
Why was the Bravo™ capsule recalled?
Beginning June 3, 2025, more than 128,000 Bravo pH capsule units were recalled after a manufacturing defect caused adhesive to be improperly applied during production. As a result, some capsules failed to attach to the patient’s esophagus as intended, while others detached during placement.
The FDA classified the action as a Class I recall, its most serious type of recall. A Class I recall is issued when there is a reasonable probability that a defective product could cause serious injury or death. In this case, the device malfunction could prevent the test from being completed and, in some cases, lead to patient complications.
What are the risks of the Bravo™ pH capsule malfunction?
A defective Bravo capsule can lead to serious injuries and medical complications, including:
- Inhalation (aspiration) of the capsule: If the capsule becomes detached and is inhaled, it can block the airway, leading to breathing difficulties, respiratory failure, or lung infections such as aspiration pneumonia.
- Airway obstruction: A Bravo capsule that fails to attach or detach properly may become lodged in the throat or airway, causing choking, chest discomfort, difficulty swallowing, or trouble breathing.
- Esophageal perforation: A tear or hole in the esophagus can allow food, liquid, or stomach contents to leak into the chest cavity, potentially causing a life-threatening infection called mediastinitis.
- Hemorrhage (internal bleeding): Improper placement or removal of the capsule may damage the esophagus and cause significant bleeding, particularly in patients with fragile tissue or pre-existing esophageal conditions.
- Esophageal laceration: The capsule may scrape or tear the lining of the esophagus during placement or if it shifts unexpectedly, resulting in pain, bleeding, or difficulty swallowing.
- Delayed diagnosis or treatment due to an incomplete test: If the capsule fails to function properly, the test may not collect enough data for an accurate diagnosis. This can delay treatment for conditions such as GERD or Barrett’s esophagus and allow symptoms to worsen.
- A retained foreign object requiring medical intervention: In some cases, the capsule may fail to detach from the esophagus or pass through the digestive tract as intended. A retained capsule may require endoscopic or surgical removal to prevent further complications.
Joining the Bravo™ capsule lawsuit
You may be eligible to pursue the Bravo capsule lawsuit if you or a loved one:
- Underwent a procedure involving a Medtronic Bravo CF capsule
- Experienced complications during or after the procedure
- Required additional medical treatment, hospitalization, or another procedure because of the device
- Suffered injuries such as aspiration, airway obstruction, esophageal perforation, internal bleeding, or a retained capsule
- Had a capsule fail to attach to the esophagus or detached unexpectedly during placement
Every case is unique and recovering from an unexpected medical complication can be overwhelming. If you believe a defective Bravo capsule caused your injuries, an attorney can help you explore your legal options.
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Bravo™ is a registered trademark of Medtronic, PLC. Their name is used here only for the purpose of identifying the products in question. Woods & Woods, LLC is not affiliated with, sponsored by, or associated with the Food and Drug Administration (FDA) or Medtronic, PLC.
