Medtronic Bravo CF Capsule Esophagus Injury Lawsuit Lawyers

National Legal Help for Patients Injured by the Recalled Bravo CF Capsule Delivery Device Used in pH Monitoring

The U.S. Food and Drug Administration (FDA) has issued a serious public safety alert involving the Bravo CF Capsule Delivery Device, a product manufactured by Medtronic and Given Imaging Inc. This device is used during esophageal pH monitoring procedures to diagnose acid reflux disease. However, due to a manufacturing defect involving improper adhesive application, the capsule may fail to attach properly or may detach from the delivery device, resulting in a range of potentially life-threatening injuries.

As of June 2025, 33 serious injuries have been reported, including:

• Esophageal perforation
• Hemorrhaging and internal bleeding
• Laceration or tearing of the esophagus
• Foreign object obstruction
• Aspiration into the lungs
• Delayed or missed medical diagnoses

This issue has led to a Class I recall—the most serious level designated by the FDA. If you or a loved one suffered complications after undergoing a Bravo pH test or if a retained Bravo capsule led to emergency treatment, you may be eligible to file a product liability or medical device injury lawsuit.

Our national civil litigation law firm is currently accepting cases involving serious injuries caused by the Medtronic Bravo CF Capsule and can help patients pursue compensation for medical expenses, pain and suffering, and long-term complications.

How the Medtronic Bravo CF Capsule Is Supposed to Work

The Bravo system is a widely used diagnostic tool for detecting gastroesophageal reflux disease (GERD). During the procedure, a small capsule is delivered through the mouth and attached to the lining of the esophagus. This capsule then measures pH levels and transmits data wirelessly to a recorder that the patient wears on their waist. Over a period of 48 to 96 hours, physicians compare reflux episodes with the patient’s recorded symptoms to determine whether reflux is present and how severe it is.

The capsule is supposed to adhere securely to the esophagus and naturally detach after a few days, passing through the gastrointestinal tract without issue. However, the manufacturing defect in the adhesive may prevent the capsule from securing properly to the esophageal lining or cause the capsule to become lodged or dislodged improperly, introducing serious risks.

When a capsule fails to attach correctly, it can cause severe injury by moving unpredictably within the esophagus or even entering the airway. In some cases, the device may remain lodged in the body, requiring emergency removal, surgery, or leading to long-term tissue damage.

Reported Injuries and Risks of the Defective Bravo CF Capsule

Medtronic has acknowledged 33 serious injuries associated with this recall. Although no deaths have been reported, the known risks include:

• Esophageal perforation: A tear or hole in the esophagus can allow stomach contents to leak into the chest cavity, leading to infections such as mediastinitis, a potentially fatal condition.
• Hemorrhage: Improper device placement can cause significant internal bleeding, especially in patients with weakened tissues or existing esophageal conditions.
• Aspiration: If the capsule becomes detached and is inhaled, it can lead to airway obstruction, respiratory failure, or lung infections.
• Obstruction and retained foreign objects: A Bravo capsule that does not attach or release correctly may become stuck, triggering choking, chest pain, or digestion issues.
• Laceration and tearing: Fragile esophageal tissues may be damaged as the capsule is inserted or shifts within the throat.
• Delayed diagnosis: A failed test can delay treatment of serious gastrointestinal conditions, allowing acid reflux disease or Barrett’s esophagus to worsen unchecked.

These complications may require hospitalization, imaging, endoscopy, or invasive surgery to remove the capsule or repair internal injuries. In the worst cases, these injuries can cause permanent damage or long-term disability.

Which Devices Are Affected by the Medtronic Recall?

According to the FDA and Medtronic, the following Bravo CF Capsule Delivery Devices are part of the recall:

Product Names and Codes:

• Bravo CF Capsule Delivery Device, 5-pk
  • Product Code: FGS-0635
  • UDI-DI: 07290101369707 / 10613994000009
• Bravo CF Capsule Delivery Device, 1-pk
  • Product Code: FGS-0636
  • UDI-DI: 07290101369714

Affected lot numbers are listed on the product’s outer label and individual packaging. If you underwent a pH monitoring procedure recently or experienced complications after such a test, your medical records may indicate whether a Bravo CF capsule from these lots was used.

Medtronic began notifying customers of the defect on June 3, 2025, followed by an updated recall notice on June 16, 2025. Medical facilities were instructed to quarantine and return unused affected devices. However, any failure to comply—or any usage of a defective product before the notice was received—could lead to injuries that form the basis of a legal claim.

Who May Qualify to File a Bravo CF Capsule Injury Lawsuit

If you or a family member experienced medical complications related to a Bravo CF capsule pH test, you may be eligible to file a personal injury or product liability lawsuit. Qualifying claims typically include:

• Esophageal bleeding, tearing, or puncture
• Hospitalization or emergency surgery due to a lodged or malfunctioning capsule
• Foreign object retention requiring additional procedures
• Respiratory distress or airway blockage following capsule delivery
• Pain, trauma, or scarring caused by improper capsule placement
• Delayed diagnosis due to device failure
• Long-term complications or disability following the procedure

Even if you’re unsure which device was used in your procedure, our legal team can help obtain and review your medical records to determine whether a recalled Medtronic product was involved.

Additionally, family members of patients who died as a result of complications caused by a malfunctioning Bravo capsule may be able to file a wrongful death lawsuit to recover compensation for funeral costs, lost financial support, and the suffering endured by the deceased prior to their passing.

How Parker Waichman LLP Can Help Victims of the Medtronic Bravo CF Capsule Recall

At Parker Waichman LLP, we represent clients nationwide in claims involving defective medical devices. Our legal team is actively investigating injury cases linked to the Bravo CF capsule recall and is helping patients and families pursue justice from Medtronic and its affiliates.

When a company releases a medical device that puts patients at risk of severe injury, it should be held accountable. Filing a lawsuit may provide compensation for:

• Past and future medical expenses
• Pain and suffering
• Lost wages or income
• Emotional trauma
• Permanent impairment
• Wrongful death damages

We offer free consultations to review your claim and help determine your legal options. If your case qualifies, you pay no legal fees unless we win compensation for you.

Contact Parker Waichman LLP For a Free Case Review

If you or someone in your family suffered injuries after undergoing an esophageal pH test using a Bravo CF Capsule, legal help is available. The Medtronic recall highlights the serious risks of this defective device—and you may be entitled to compensation for your injuries, pain, and medical expenses.

Call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. We are accepting claims nationwide and will fight to hold Medtronic accountable. You pay no legal fees unless we recover compensation on your behalf. Don’t wait—your time to file a claim may be limited.