Medtronic Bravo CF Capsule Recall Linked to 184 Serious Injuries

FDA Issues Safety Alert Over Esophageal Monitoring Device That May Fail During Placement

What Parker Waichman LLP Found

• The FDA reported 184 serious injuries and no deaths associated with the current Bravo CF issue as of August 10, 2026.
• Device failures may cause aspiration, airway obstruction, esophageal perforation, bleeding, laceration, retained foreign material, and delayed diagnosis.
• A previous Bravo CF recall involving a similar attachment or detachment failure was ultimately designated Class I by the FDA and was associated with 33 reported serious injuries.
• Patients pursuing claims may need hospital records, product numbers, lot information, UDI data, medical bills, and records documenting additional procedures or lost income.
• A recall alone does not establish liability, but patients seriously injured by a malfunctioning Bravo CF device may have grounds to investigate a medical device product liability lawsuit.

Federal regulators are warning patients and health care providers about a potentially serious problem involving certain Medtronic Bravo CF Capsule Delivery Devices used to diagnose gastroesophageal reflux disease, commonly known as GERD. The U.S. Food and Drug Administration issued an Early Alert on August 27, 2026, after Medtronic and its subsidiary, Given Imaging, Inc., began removing affected devices from use and sale. According to the FDA, Medtronic reported 184 serious injuries associated with the problem as of August 10, 2026. No deaths had been reported at the time of the FDA announcement.

The reported malfunction is especially concerning because it can occur while a medical device is being placed inside the esophagus. The Bravo CF capsule may fail to attach to the esophageal wall as intended or may fail to detach properly from the delivery device used by the physician. The FDA warns that the resulting complications can include aspiration or inhalation of the capsule, airway obstruction, esophageal perforation, laceration, hemorrhage, retained foreign material, and delayed diagnosis.

Patients who suffered a serious injury after a Bravo CF procedure may have questions extending far beyond the immediate medical treatment they received. Depending on the circumstances, an injured patient may need to determine which device was used, whether it belonged to a recalled lot, what happened during the procedure, whether additional medical intervention was required, and whether the available evidence supports a product liability claim.

What Is the Medtronic Bravo CF Capsule Delivery Device?

The Bravo system is used to help physicians evaluate patients for acid reflux and related gastrointestinal conditions. The system involves placing a small pH-monitoring capsule against the lining of the esophagus. Once attached, the capsule measures acidity in the esophagus and transmits information to a recorder. Physicians can then compare the recorded pH information with the patient’s symptoms and determine whether episodes of acid reflux may explain those symptoms.

This type of diagnostic testing can be valuable because symptoms such as persistent heartburn, chest discomfort, coughing, difficulty swallowing, regurgitation, or throat irritation do not always have a simple cause. The monitoring system is intended to give doctors objective information about acid exposure over time.

The procedure, however, depends upon the capsule and its delivery mechanism functioning correctly. A device that does not attach where intended or does not properly separate from the placement instrument can create an entirely different medical problem from the condition doctors were attempting to diagnose.

The current FDA concern centers on the Bravo CF capsule delivery system rather than merely the diagnostic data generated by the capsule. According to Medtronic’s information provided to the FDA, a problem involving the component controlling deployment may prevent normal attachment or detachment. The FDA further reports that the problem may be aggravated if the delivery device is not maintained in a straight position as directed by the product’s User Guide.

FDA Reports 184 Serious Injuries Associated With the Bravo CF Problem

The number of reported serious injuries makes the August 2026 alert particularly significant. Medtronic reported 184 serious injuries associated with the issue as of August 10, according to the FDA. The agency reported no associated deaths at that time.

An injury involving the esophagus or airway can become medically urgent very quickly. The esophagus is positioned near the airway and other important structures in the chest. A device failure during placement can therefore involve more than temporary discomfort.

The FDA identified a range of potential consequences, including aspiration or inhalation of the device, obstruction of the airway, perforation of the esophagus, laceration, bleeding or hemorrhage, a foreign object remaining inside the patient, and delays in receiving the correct diagnosis.

Some patients may require endoscopy or another procedure to retrieve a misplaced or retained capsule. More serious events could require emergency airway management, hospitalization, surgery, blood-loss treatment, or continued monitoring for damage to the esophagus and surrounding tissues.

The medical consequences may also continue after the initial emergency has passed. A patient could potentially experience persistent swallowing problems, pain, infection, gastrointestinal complications, scarring, anxiety surrounding additional procedures, or the need for follow-up diagnostic testing.

For a potential lawsuit, the severity and duration of the injury can become important when evaluating medical expenses, future treatment, lost earnings, physical pain, emotional suffering, and other damages allowed under applicable state law.

Why Did Medtronic Recall Certain Bravo CF Capsule Delivery Devices?

On August 6, 2026, Medtronic notified affected customers that certain Bravo CF capsule delivery devices should be removed from use. The FDA subsequently issued its Early Alert on August 27.

According to the FDA, Medtronic determined that the Bravo CF capsule might not attach to the patient’s esophagus or might not detach correctly from the delivery device. The company reported that these failures may involve a problem with the component responsible for controlling capsule deployment.

The current recall affects Bravo CF five-pack capsule delivery devices identified by product number FGS-0635 and one-pack devices identified by product number FGS-0636. The FDA’s Early Alert identifies affected lots with expiration dates through October 20, 2027, and notes that lots with expiration dates of December 10, 2027, or later are outside the scope of the recall.

Patients should not attempt to determine their recall status from the procedure date alone. The product number, lot number, expiration date, hospital inventory information, and procedural records may all be important.

Medtronic instructed customers to identify and quarantine affected unused devices and return them to the company for replacement. The company also directed customers to communicate the notice to others within their organizations and to organizations that may have received transferred or distributed devices.

The 2026 FDA Alert Follows a Previous Bravo CF Class I Recall

The current issue is not the first serious safety concern involving Bravo CF capsule delivery devices.

In June 2025, Medtronic and Given Imaging notified customers about another problem that could cause a Bravo CF capsule to fail to attach to the esophagus or detach from its delivery system. In that earlier recall, the problem was attributed to adhesive being incorrectly applied during manufacturing. Medtronic reported 33 serious injuries and no deaths associated with that problem.

The FDA subsequently classified the 2025 action as a Class I recall. A Class I designation is the FDA’s most serious recall classification and applies when there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The FDA updated the earlier Bravo CF communication on January 5, 2026, to reflect the Class I classification.

The FDA says the failure experienced by users in the 2026 action is the same type of failure described in the previous recall, although the underlying cause is different.

That distinction could become important during a product liability investigation. Attorneys evaluating a claim may examine when the manufacturer first became aware of similar failure modes, what testing occurred after previous reports, what corrective measures were implemented, whether additional failures were foreseeable, and how subsequent devices were manufactured and evaluated.

As of the FDA’s August 27 announcement, the agency was still reviewing the 2026 issue and had not announced a final recall classification. The current action should therefore not be inaccurately described as an already-classified Class I recall. The FDA describes it as an Early Alert concerning a potentially high-risk device issue.

What Injuries Can a Defective Bravo CF Capsule Cause?

A failure involving an internally placed diagnostic device can create several mechanisms of injury. The exact medical consequences will depend on where the capsule goes, whether it becomes lodged, whether the esophageal wall is damaged, how quickly physicians recognize the malfunction, and what intervention becomes necessary.

Esophageal perforation is among the most serious complications identified by the FDA. A perforation means an opening or tear develops through the esophageal wall. Such an injury may allow fluids, food, or bacteria to enter tissues surrounding the esophagus and can result in severe infection and other complications.

Airway obstruction presents a different danger. If the capsule enters or blocks the respiratory tract, the patient’s ability to breathe may become compromised and immediate intervention may be necessary.

Aspiration or inhalation of the capsule can similarly require urgent retrieval. The FDA has previously documented aspiration concerns involving Bravo products. An earlier FDA recall record involving Bravo capsules warned that capsule aspiration could result in low oxygen levels, retrieval procedures, possible intubation, a longer hospital stay, and treatment delays.

Esophageal laceration and bleeding may occur when tissue is injured during failed deployment, detachment, removal, or retrieval. Depending upon its severity, bleeding may require monitoring, additional endoscopy, transfusion, surgery, or other treatment.

A retained foreign body can require another procedure to locate and remove the device. Beyond the physical risks, patients may incur new hospital charges and experience additional time away from employment and family responsibilities.

Delayed diagnosis is another consequence specifically identified by the FDA. A person undergoing Bravo testing generally already has symptoms requiring medical investigation. When the diagnostic procedure itself fails or leads to an injury, diagnosis and treatment of the original gastrointestinal condition may be postponed.

Compensation in a Medtronic Bravo CF Injury Lawsuit

Patients who establish a legally viable product liability claim may be able to seek compensation for losses caused by their injuries. Recoverable damages depend upon applicable state law and the circumstances of the case.

Medical damages can include emergency treatment, hospitalization, endoscopy, surgery, physician visits, diagnostic imaging, medication, rehabilitation, and future treatment related to the injury. A person who misses work or becomes temporarily or permanently unable to perform previous employment may also have a claim for lost income or diminished earning capacity where permitted.

Non-economic damages may compensate for physical pain, emotional distress, disfigurement, disability, loss of normal activities, or reduced quality of life. The rules governing these damages and any applicable limits differ substantially from state to state.

A patient who suffered a temporary problem resolved immediately during the procedure will likely present a substantially different damages analysis from someone who experienced an esophageal perforation, emergency surgery, intensive care treatment, or long-term impairment.

An attorney evaluating a case will therefore look not only at whether the product malfunctioned but also at precisely what harm followed from the malfunction.

What Patients Should Do After a Suspected Bravo CF Injury

Anyone experiencing a current medical emergency, breathing difficulty, severe chest pain, significant bleeding, difficulty swallowing, or other potentially serious symptoms should seek appropriate medical care rather than delaying treatment for legal reasons.

Once the patient’s immediate health needs have been addressed, obtaining records can help clarify what occurred. Patients can request records from the facility where the Bravo procedure was performed and from hospitals or physicians who treated any complications.

It may also be important to determine the exact device identification information. Product number, lot number, UDI information, expiration date, inventory records, and recall status can help establish whether the device falls within one of Medtronic’s affected groups.

Patients should preserve bills, insurance explanations of benefits, photographs, written instructions, recall correspondence, employment records documenting missed work, and information concerning additional procedures.

The FDA also encourages health care professionals and consumers to report adverse reactions or product quality problems through its MedWatch program.

Time Limits Can Affect Medtronic Bravo CF Lawsuits

Every state imposes deadlines governing product liability and personal injury actions. Those deadlines are commonly referred to as statutes of limitations. Additional statutes of repose may apply in some jurisdictions.

The applicable deadline cannot safely be determined simply by looking at the date of an FDA recall. Depending on state law, relevant dates may include when the procedure occurred, when the injury occurred, when the patient discovered or reasonably should have discovered the connection between the injury and product, or other events.

Waiting for additional FDA action before speaking with an attorney can therefore create unnecessary risk. Evidence can also become more difficult to obtain with time. Hospitals may have document-retention policies, personnel may change jobs, physical products may be discarded, electronic data may be overwritten, and recollections may fade.

Early investigation gives attorneys a better opportunity to identify the product and preserve relevant evidence before it disappears.

Injured by a Medtronic Bravo CF Capsule? Parker Waichman LLP Can Review Your Case

A medical procedure intended to determine the cause of gastrointestinal symptoms should not leave a patient facing an airway emergency, esophageal injury, additional surgery, hospitalization, or other serious complication. If you or a family member suffered an injury following placement of a Medtronic Bravo CF capsule, determining exactly which device was used and preserving the evidence surrounding the procedure may be critical.

Parker Waichman LLP represents injured consumers in product liability and defective medical device cases nationwide. Our attorneys can investigate the circumstances surrounding the procedure, obtain relevant medical and product identification records, determine whether the device was included in an affected recall, evaluate the medical consequences of the malfunction, and assess the claims that may be available under applicable law.

There is no charge to learn whether you may have a case. Call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. Because statutes of limitations and other filing deadlines can affect product liability claims, injured patients should consider having their circumstances reviewed as soon as possible. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.