Legal Help for Victims Harmed by Recalled Bravo CF Capsule Devices – Now Accepting Cases Nationwide

Medtronic Bravo CF pH Monitoring Capsule Recall: A Growing Safety Crisis for Patients

The U.S. Food and Drug Administration (FDA) has issued a high-priority warning regarding the Medtronic Bravo CF Capsule Delivery Device, following multiple reports of serious patient harm. Designed to assist doctors in diagnosing acid reflux (GERD), this medical device is intended to attach to the esophagus and transmit pH data. However, a manufacturing defect has led to dangerous complications—including esophageal injuries, airway obstructions, and foreign object retention.

As of June 2025, 33 serious injuries have been reported, and the FDA has labeled this a Class I recall, indicating the highest level of risk for patient harm or death.

The problem lies in the misapplication of adhesive during manufacturing, which may cause the capsule to fail to attach properly to the esophagus or to detach incorrectly from the delivery device. When this happens, the capsule may move unpredictably, lodge in the throat, injure the esophagus, or even obstruct the airway.

If you or a loved one suffered complications following a procedure involving a Medtronic Bravo CF capsule, you may be eligible to pursue financial compensation through a product liability or wrongful death lawsuit. Our national civil litigation law firm is actively accepting injury and death claims linked to this recalled device.

Understanding the Medtronic Bravo CF Capsule and How It’s Used

The Bravo pH monitoring system is a commonly used diagnostic tool for evaluating gastroesophageal reflux disease (GERD). It involves the insertion of a small capsule that adheres to the esophageal lining. The capsule monitors the pH (acid) levels in the esophagus and wirelessly transmits data to a recorder worn by the patient. Physicians then use this information to compare pH patterns with reported symptoms and determine if the patient suffers from acid reflux.

The intended process is minimally invasive and should be safe when the device functions correctly. But when manufacturing errors affect adhesion, the consequences can be immediate and severe. Rather than staying securely in place, the Bravo capsule may fall off, migrate into the throat or lungs, or cause tears, bleeding, or pressure injuries to the esophageal wall.

Medtronic’s recall affects a wide distribution of devices and includes both single- and multi-pack units, raising concern about how many patients may be at risk.

Reported Injuries and Health Risks from the Recalled Bravo Capsule

The FDA and Medtronic have confirmed 33 known serious injuries associated with the defective Bravo CF Capsule Delivery Device. No deaths have been confirmed so far, but the risks are significant and ongoing. Known complications include:

  • Esophageal perforation – A puncture or tear in the esophagus can cause internal bleeding and potentially fatal infections.
  • Aspiration and airway obstruction – Detached or loose capsules may migrate into the airway, causing respiratory distress or choking.
  • Hemorrhage – Bleeding within the esophagus from physical trauma caused by the capsule.
  • Foreign object retention – The capsule may not pass through the digestive tract and instead remain inside the body, requiring surgical removal.
  • Lacerations or tears – Mechanical trauma to soft tissue during insertion or dislodgement.
  • Delayed diagnosis or failed procedure – The test’s failure to collect accurate pH data may result in missed or delayed treatment for acid reflux or Barrett’s esophagus.

Some patients may not realize right away that a device malfunction has occurred. Symptoms such as chest pain, throat irritation, shortness of breath, difficulty swallowing, or persistent coughing after a pH test should be taken seriously and evaluated immediately by a medical professional.

Medtronic’s Recall and the FDA’s Warning

Medtronic, along with its subsidiary Given Imaging Inc., issued a recall for affected lots of the Bravo CF Capsule Delivery Device on June 3, 2025, with an update sent to customers on June 16, 2025. The FDA is actively monitoring the situation and has designated this as a Class I recall, meaning there is a reasonable probability that use of the product could cause serious health consequences or death.

Affected product codes include:

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

Facilities and providers were instructed to identify, quarantine, and return all unused affected devices. However, thousands of procedures may have already been performed using these defective capsules—many of which may have resulted in unrecognized injury or long-term harm.

Who May Qualify to File a Bravo CF Capsule Injury or Wrongful Death Lawsuit?

If you or your loved one underwent a pH monitoring procedure using a Bravo capsule and experienced medical complications, you may be eligible to file a lawsuit against Medtronic or other parties involved in the device’s distribution or use.

Qualifying cases may involve:

  • Emergency hospitalization after the test
  • Surgery to remove a retained or dislodged capsule
  • Hemorrhaging or confirmed internal bleeding
  • Diagnosed esophageal tears or punctures
  • Breathing complications or aspiration events
  • Severe pain or prolonged recovery linked to the test
  • Incomplete or failed diagnostic results
  • Death resulting from device-related complications

In wrongful death cases, family members may be eligible to recover damages for funeral costs, medical bills, lost future income, and emotional loss.

Even if you’re unsure whether a Medtronic Bravo capsule was used, we can help investigate your medical records and determine whether you qualify for compensation.

Legal Options and Compensation for Injured Patients

A product liability lawsuit can provide victims and their families with critical financial support and a path toward justice. Compensation may include:

  • Medical expenses – Hospital stays, surgeries, medications, follow-up care
  • Lost wages – Income missed during recovery or disability
  • Pain and suffering – Physical pain, emotional trauma, and reduced quality of life
  • Permanent impairment – Compensation for long-term complications
  • Wrongful death damages – Funeral expenses, loss of companionship, and more

When a medical device fails during a procedure, the consequences can be life-altering. Our attorneys have experience holding major device manufacturers accountable and are prepared to fight for patients affected by this recall.

Parker Waichman LLP Is Accepting Bravo CF Capsule Lawsuits Nationwide

At Parker Waichman LLP, we represent victims of defective medical devices across the United States. Our legal team is now reviewing injury and wrongful death claims linked to the Medtronic Bravo CF Capsule Delivery Device recall.

We will work with medical experts, review surgical records, and handle every step of your claim from start to finish. If you or a family member was harmed during or after a pH test using this device, don’t wait. Time limits apply for product liability and wrongful death lawsuits, and early investigation improves the chances of a successful claim.

Contact Parker Waichman LLP For a Free Case Review

If you or a loved one was harmed by the Medtronic Bravo CF Capsule Delivery Device, legal support is available. Whether you suffered internal injury, underwent emergency surgery, or lost a family member due to complications after a pH monitoring procedure, you may be entitled to financial compensation.

Call Parker Waichman LLP now at 1-800-YOUR-LAWYER (1-800-968-7529) for your free case review. Our medical device injury attorneys represent clients nationwide in medical device injury and wrongful death lawsuits. There are no legal fees unless we recover compensation for you. Time is limited—act today to protect your rights and seek justice.

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