Medtronic is currently facing legal claims due to product defects involving its Bravo acid reflux testing system. The purpose of these devices was to diagnose gastroesophageal reflux disease (GERD). However, a defect is causing them to fail when deployed. Patients injured may seek financial compensation through product liability lawsuits.
The FDA Has Issued a Class I Recall for Medtronic Bravo Reflux Testing Systems
The U.S. Food and Drug Administration (FDA) has issued an early alert notifying consumers of an ongoing high-risk device issue associated with the Bravo calibration-free (CF) esophageal pH monitoring capsules by Medtronic.
The affected products are:
- Bravo CF capsule delivery device, 5-pk. Product number: FGS-0635. UDI-DI: 07290101369707.
- Bravo CF capsule delivery device, 1-pk. Product number: FGS-0636. UDI-DI: 07290101369714.
The FDA has recommended that these delivery devices be recalled and removed from use. The purpose of the recall is that the capsule might not attach to the esophagus or detach from the delivery device as intended, causing serious patient harm.
Serious Injuries Have Been Connected to the Defective Medtronic Devices
As of August 10, 2026, Medtronic reported 184 serious injuries and no deaths in association with the defective Bravo CF devices.
Reported injuries include:
- Internal trauma
- Perforations of the esophagus
- Esophageal tears or lacerations
- Severe internal bleeding (hemorrhage) or blood loss
- Capsule aspiration or inhalation
- Airway obstruction
- Foreign bodies being retained in the patient
- Delays in GERD diagnoses
These and other severe complications can be caused by the defective pH testing capsules due to device failure. The reported injuries have triggered a high-priority Class I medical device recall by the FDA.
Understanding Product Liability Claims for Bravo CF Testing Systems
Investigations have so far traced the Medtronic device failure back to misapplied adhesive during the manufacturing process, which causes the capsules to detach incorrectly from the delivery devices and fail to attach to the esophagus as intended. This is a product defect that can make affected victims eligible for financial compensation through the legal doctrine of product liability.
In general, it is not necessary to prove negligence to have a successful product liability claim. Under the rule of strict liability, it is only required to establish that the device in question contained a defect and caused the claimant harm or injury.
In 2025, Medtronic recalled a subset of lots included in the latest 2026 recall because of the same defect, but the company reported a different underlying cause. Since this issue is a product defect and not a design problem, this should prevent the preemption defense from being used to block lawsuits against the manufacturer.
Types of Financial Compensation Recoverable
A product liability claim filed due to the defective Medtronic Bravo CF devices could lead to financial compensation for the victim’s present and foreseeable losses. Recoverable compensation may include:
- Related medical expenses
- The costs of surgical device removal or repair
- Emergency treatments
- Lost wages due to injury or recovery
- Long-term damage or disability
- Physical pain and emotional distress
To discuss the potential compensation that may be available to you as a victim of the defective Medtronic GERD testing devices, consult with a product liability attorney from Goldenberg Lauricella.
Contact Goldenberg Lauricella, PLLC to Find Out if You Have a Case
Goldenberg Lauricella, PLLC, is currently accepting legal cases from patients who have suffered harm due to defective Medtronic Bravo CF capsule devices. We are a highly experienced and reputable law firm with over 40 years in this area of law and $200 million recovered for clients, including over $36 million in product liability claims.
We offer free initial consultations, where you can find out if you have grounds for a defective medical device claim at no cost or obligation to hire us. Contact us online now or call (612) 333-4662 anytime to learn more about the Medtronic Bravo reflux testing system recall.
What can make a medical device defective?
A device manufacturer may be held liable for defective design, defective manufacturing, and/or failure to warn of serious risks they were aware of with the medical device but did not disclose. Medical device defects are categorized as either design defects or manufacturing defects.
What is a design defect?
A design defect is a defect that is part of the basic design of the product and renders the product unsafe for use.
What is a manufacturing defect?
A manufacturing defect can occur as an unintended consequence of the manufacturing process. Examples include contamination and flaws in making the product.
What should I do if I am injured by a defective medical device?
Being injured by a defective medical device is a scary experience, and the process of filing a defective medical device lawsuit can be complex. If you or a loved one have been injured by a defective medical device, contact the team at Goldenberg Lauricella, PLLC. We have over 30 years of experience litigating defective medical device lawsuits for thousands of clients and obtaining justice through settlements.
Should I accept a direct settlement from a device manufacturer if one is offered?
If you receive a direct settlement offer from a device manufacturer, contact the attorneys at Goldenberg Lauricella, PLLC. We will evaluate your case to review any offer and help you make the best decision possible.
What is a multidistrict litigation, & why is it used for defective medical device cases?
A multidistrict litigation (“MDL”) is a procedural creation where federal civil (noncriminal) cases throughout the country are transferred to one court. The establishment of an MDL is intended to reduce the burden on federal district courts, make litigation more convenient for all the parties involved, and promote overall efficiency by resolving common questions throughout the case that occur in large-scale defective medical device lawsuits. In order for the cases to be consolidated, they must have one or more questions of fact in common. Once the cases are consolidated, one judge manages the litigation during the pretrial and discovery processes. However, each case will be resolved based on its own merits.
If you have any questions, or if you would like to speak with an attorney regarding your defective medical device injury, please do not hesitate to call our medical device attorneys at (800) 903-1643. If you prefer, you may fill out the form on the “Contact Us” page of this web site, and a representative from our office will be in touch with you shortly.