Medtronic Bravo Capsule Recall Lawyer: Esophageal Injury Claims

This page is for people who had a Bravo esophageal pH test, usually during an upper endoscopy for heartburn or reflux, and then had something go wrong: a torn esophagus, bleeding, a capsule in the airway, or a failed test that had to be repeated. It’s also for family members trying to make sense of a hospital stay that started with a routine reflux study.

We’re Fob & Foster Personal Injury Lawyers in Birmingham, Alabama. We review Bravo capsule claims from anywhere in the country by phone or video and work alongside national co-counsel on cases filed outside Alabama. We’ll tell you straight what the recall records show and whether your dates and injuries fit a claim.

What the Bravo Test Is and How the Capsule Is Supposed to Work

The Bravo test measures how often stomach acid backs up into the esophagus. Older tests left a thin tube in the nose for a full day. Bravo replaces the tube with a small wireless capsule that sits against the esophageal wall and sends pH readings to a receiver the patient keeps nearby. The current version is the Bravo CF (calibration-free) reflux testing system, sold by Medtronic and Given Imaging, the two companies named in the FDA’s recall notices. According to Medtronic, it’s indicated for adults and children 4 and older.

Bravo Capsule Placement and What the Capsule Looks Like

A gastroenterologist usually places the capsule during an upper endoscopy while the patient is sedated. The capsule is small and smooth, roughly the size of a gel-cap pill, and rides on the end of a long, thin delivery device. It’s pressed against the lining above the stomach, suction draws a bit of tissue into it, and it locks onto that tissue. The delivery device comes back out and the capsule stays behind. Your endoscopy report may include a photo of it in position.

Recording runs 48 to 96 hours. The patient eats, sleeps and works normally and logs meals and symptoms so the doctor can match acid events to heartburn, coughing or chest pain.

How the Bravo Capsule Detaches

Nobody goes back in to retrieve it. The capsule is designed to let go of the esophageal wall on its own after the test, then pass through the digestive tract and leave the body in stool. If there’s a question whether it’s still attached, a doctor may order an X-ray or another endoscopy. Placement has to go right for the test to be safe: the capsule has to attach firmly to the esophageal wall and then release cleanly from the delivery device. Both recalls are about that step. Days later, the capsule also has to come off the wall without tearing anything.

The Two Bravo CF Recalls Compared: 2025 Adhesive Recall vs. 2026 Deployment Recall

Some coverage online lumps these together. They have different causes, different lot ranges and very different injury counts, and which one your capsule falls under changes how we investigate your case.

The two recalls are similar in size, each about 128,000 units in commerce according to the FDA’s recall database, but they differ in cause and in reported injuries. The 2025 recall traced the problem to a manufacturing step. The 2026 recall points at a deployment component, and its injury count is more than five times the first recall’s. The FDA’s 2026 notice says some of its lots were already part of the June 2025 recall, and it tells facilities not to use affected devices.

Under FDA rules, Class I is reserved for situations where there’s a reasonable probability that using a product will cause serious health problems or death. Two Class I recalls of the same capsule, announced about fourteen months apart, get a product lawyer’s attention. So does history. The FDA’s recall database lists earlier Class 2 recalls involving the same kinds of failures: a 2007 recall of 169,365 Bravo capsule and delivery systems sold worldwide because the capsule might not detach from the delivery system after attaching to the esophageal wall; a 2012 recall of 21,885 units for failure to attach or to detach from the placement device; and a 2021 recall that included Bravo CF product numbers FGS-0635 and FGS-0636 because the capsule might fail to attach and be aspirated, after 13 aspiration reports in two years. Whether those put the company on notice is a question for discovery.

What Can Go Wrong When a Bravo Capsule Fails

The FDA’s 2026 notice lists the risks associated with the problem: aspiration or inhalation of the capsule, airway obstruction, esophageal perforation, esophageal laceration, hemorrhage or bleeding, delayed diagnosis or treatment, and foreign objects remaining in the body. Here’s what those mean for a patient.

Esophageal Perforation and Laceration

A perforation is a hole through the full wall of the esophagus. It’s the most dangerous injury on the list, because saliva and stomach contents can leak into the chest and cause serious infection. Treatment usually means a hospital admission, nothing by mouth, IV antibiotics and often an endoscopic repair with clips or a stent. Some patients need surgery, and some are left with scarring that narrows the esophagus. A laceration is a tear that doesn’t go all the way through. It can still cause painful swallowing, chest pain and bleeding.

Bleeding

Bleeding may show up as vomiting blood, vomit that looks like coffee grounds, or black, tarry stools. Heavier bleeding can require a repeat endoscopy, a transfusion and an overnight stay.

Aspiration and Airway Obstruction

A capsule that fails to attach or comes loose in the throat can be breathed into the windpipe or lungs instead of swallowed, and a sedated patient may not cough it up. An inhaled capsule can block part of the airway. Getting it out usually takes a bronchoscopy, another procedure under sedation, and pneumonia can follow.

Retained Capsule and Delayed Diagnosis

Sometimes the capsule doesn’t come off, or part of the device stays behind, and it may have to be removed endoscopically. At the other end, a capsule that falls off early or never attaches means the study fails. That can mean a second test, more sedation, and months of delay before a reflux diagnosis or surgery decision. A failed study alone is usually a smaller claim, but the FDA lists delayed diagnosis as a risk, and it often travels with other injuries.

Normal Bravo Test Discomfort vs. Warning Signs

Many people reading this are mid-test and worried. Some discomfort is common while the capsule is in place: a feeling that something is stuck, mild chest discomfort, or pain when eating, especially with dry or bulky food. Small bites and slow chewing usually help, and those sensations tend to ease once the capsule detaches. Follow your endoscopy center’s written instructions.

Call your doctor, go to an emergency room or call 911 if you have any of these after a Bravo placement:

• Chest pain that is severe or getting worse
• Trouble swallowing, or being unable to swallow your own saliva
• Vomiting blood or material that looks like coffee grounds, or black stools
• Shortness of breath, wheezing, choking or a new cough that won’t stop
• Fever or chills

Don’t wait for the recording period to end. Tell the ER doctor you had a Bravo capsule placed and on what date, so it gets into the record. We’re lawyers, so treat this section as a reason to call your physician rather than as medical advice.

How to Find Out Whether Your Bravo Capsule Was Recalled

Almost nobody knows their capsule’s lot number. You were sedated, and the box went in the trash. The answer lives at the hospital or endoscopy center, which typically logs the device’s unique device identifier (UDI), product number, lot and expiration date. Ask medical records for these items by name; “my records” often gets you a two-page visit summary.

Then compare the lot with the FDA’s lists. The 2025 recall covers hundreds of FGS-0635 and FGS-0636 lots in the FDA’s recall database, not only the four lots shown in the FDA’s notice. The 2026 recall covers lots 64553F through 68912F, all expiring on or before October 20, 2027. The FDA says some lots fall under both recalls. If the facility won’t release lot information, call us. A lawyer’s records request often gets further than a patient’s phone call.

Who May Have a Bravo Capsule Claim

We’re reviewing cases where a Bravo CF capsule failed to attach, detached wrong or didn’t detach, and the patient suffered a real injury. The strongest involve:

• Esophageal perforation or a tear confirmed by imaging or endoscopy
• Bleeding that needed a repeat endoscopy, transfusion or admission
• A capsule inhaled into the airway, or a bronchoscopy to remove it
• A retained capsule or device part removed in a second procedure
• A failed study plus delayed treatment with real consequences
• Any of these injuries in a child (the device is indicated for ages 4 and up)

A recalled lot makes a case cleaner, but a capsule outside the listed lots that failed the same way may still be worth a look. We’ll be candid, too: mild throat discomfort that resolved without added treatment usually isn’t a case worth filing.

Records That Prove a Bravo Capsule Injury Case

A device case is built on paper. The recall notices tell us what Medtronic and the FDA said about the product. Your records have to show that your capsule was affected, that it failed, and what the failure cost you. You can start on most of this today.

One time-sensitive step: if your capsule or delivery device was retrieved in a later procedure, ask the hospital in writing to keep it and not discard it or return it to the manufacturer without telling you. Physical evidence in a device case is valuable, and once it’s gone, it’s gone.

How a Bravo Capsule Recall Case Is Built

What a Recall Proves, and What It Doesn’t

People assume a Class I recall means the company automatically owes them. It doesn’t work that way. A recall is strong evidence that the manufacturer and the FDA believed certain devices had a problem. It doesn’t prove your capsule was defective, that the defect caused your injury, or what your damages are. Expect Medtronic to argue that tears and bleeding can happen with any Bravo placement; its own product information lists esophageal tears, perforation and bleeding as possible complications. We have to show the link with your records.

Manufacturing Defect and Design Defect Claims

The 2025 recall reads like a textbook manufacturing problem: the FDA said adhesive was misapplied during manufacturing, meaning the units left the factory different from their design. If your capsule came from a 2025-recall lot, that’s the theory we’d lead with. The 2026 recall points at a deployment component and at how the delivery device must be held, which raises design and instruction questions. Was the mechanism too prone to failure? Were physicians told clearly, and early enough, to keep the delivery device straight?

FDA Reports, Company Knowledge and Preemption

Manufacturers must report certain device problems to the FDA, and the 2026 count of 184 serious injuries came from somewhere. In a lawsuit, we’d seek complaint files, internal testing, adverse event reports and the engineering work behind both Class I recalls and the earlier Class 2 recalls. What the company knew, and when, is what drives punitive damages in many states. Expect the defense to raise federal preemption anyway. The FDA’s recall records list the Bravo CF delivery device under a 510(k) clearance (K102543), not premarket approval. Under Medtronic, Inc. v. Lohr (1996), 510(k) clearance generally does not preempt state-law injury claims the way premarket approval can under Riegel v. Medtronic (2008), though defendants sometimes make other preemption arguments. We check that history early because it shapes how claims are pleaded.

What About the Doctor or the Endoscopy Center?

In most recall cases the claim runs against the manufacturer. The FDA’s notices put the problem in the product: misapplied adhesive in 2025 and a deployment component in 2026. Your doctor and the facility had no practical way to see either defect when they opened the package.

The 2026 notice did say that not keeping the delivery device straight can worsen the failure. Whether that instruction reached providers, and how a given placement went, are fact questions the records will answer. We don’t start a case by blaming the people who treated you. Your gastroenterologist and the endoscopy center are usually the best sources of records about what the device did.

Filing Deadlines for Bravo Capsule Injury Claims Vary by State

Every state sets its own statute of limitations for injury claims, and some also have a statute of repose that cuts off product claims after a fixed number of years. Many states allow two years. Tennessee and a few others allow one. Some allow longer. Where you live, where the test was done and where the case is filed can point to different states. Here’s how the rules generally look in three states we see often:

When the Clock Starts on a Bravo Injury

In many drug cases, people don’t connect an illness to a medication for months. Bravo injuries usually show up within hours or days, so you should generally assume the clock started on or near the procedure date or your first treatment for the injury. Some states delay the start until you knew or should have known the cause, but don’t count on it.

The first recall’s customer letters went out in June 2025. A Tennessee patient hurt in mid-2025 may already be at or past one year. Repose is rarely the problem with a device this recent. Please don’t calculate your own deadline from a chart. Call with your procedure date and we’ll tell you where you stand.

Why No Bravo Capsule Lawsuit Has Been Filed Yet, and Why You Shouldn’t Wait

As of October 20, 2026, no Bravo injury lawsuits have been reported filed, and the Judicial Panel on Multidistrict Litigation’s October 1, 2026 list of pending MDL dockets shows no Bravo proceeding. Firms nationally, ours included, are investigating. That’s normal for a recall classified only on September 15, 2026; careful lawyers confirm lot numbers and records before filing.

None of that stops your deadline. The statute of limitations runs whether or not anyone else has sued, device logs get archived, and retrieved devices get thrown out. A review now doesn’t commit you to filing. It tells you what you have and how long you have.

What a Bravo Capsule Injury Claim May Be Worth

There are no Bravo settlements or verdicts yet, and anyone quoting an average payout is guessing. These are the facts that move value in a device injury claim:

• Severity. A perforation that needed surgery or a stent is a different case from a failed study repeated a month later.
• Extra procedures and hospital time. Each bronchoscopy, repeat endoscopy or admission adds cost and risk.
• Lasting effects. A narrowed esophagus, ongoing swallowing trouble or lung complications weigh heavily.
• Bills and lost income, past and future, including a family member’s time off to care for you.
• Proof your capsule was affected. A documented lot or expiry match is worth a great deal; a missing lot record is a problem to solve.
• Your health before the test, which the defense will comb for other explanations.
• State law. Tennessee generally caps noneconomic damages; Alabama’s contributory negligence rule is a defense we plan around from day one.

What to Do This Week If a Bravo Capsule Hurt You

1. Get medical care first if you have any warning sign above, and keep every follow-up.
2. Write your timeline tonight: procedure date, facility, doctor, when symptoms started, every ER visit and procedure since.
3. Request the procedure report and device log with UDI, product number, lot and expiration date.
4. Ask in writing that any retrieved device be preserved.
5. Keep every recall letter, bill and insurance statement in one folder.
6. Don’t sign anything from the manufacturer or an insurer without a lawyer reading it.
7. Call for a free review before your deadline gets close.

Medtronic Bravo Capsule Lawsuit Timeline

No Bravo injury litigation has started, so this timeline tracks regulatory events. We’ll add court filings as they happen.

October 20, 2026 – No Bravo Injury Lawsuits Reported; Firms Investigating

No personal injury suits or MDL have been reported. Firms nationally are reviewing claims.

September 15, 2026 – FDA Classifies Second Bravo CF Recall as Class I

The deployment-component recall covering FGS-0635 and FGS-0636 lots 64553F through 68912F, all expiring on or before October 20, 2027, receives the FDA’s most serious classification.

August 27, 2026 – FDA Early Alert on Second Recall

The FDA warns the capsule may not attach to the esophagus or detach from the delivery device as intended. Its notice tells facilities not to use affected devices.

August 10, 2026 – 184 Serious Injuries Counted

The FDA’s notice says Medtronic had reported 184 serious injuries and no deaths as of this date.

August 6, 2026 – Customer Letter Starts Second Recall

According to the FDA’s notice, a customer letter on this date began the second Bravo CF recall.

January 5, 2026 – First Recall Classified as Class I

The 2025 adhesive recall is classified Class I, with 33 serious injuries and no deaths reported.

June 24, 2025 – FDA Early Alert on Adhesive Recall

The FDA reports capsules may not attach to the esophagus or detach from the delivery device as intended because of adhesive misapplied during manufacturing.

June 3 and June 16, 2025 – Customer Letters Start First Recall

Medtronic and Given Imaging notify customers. The June 16 update tells them the listed lot numbers appear on both the 5-pack and 1-pack labels and to recheck inventory against the full list.

February 26, 2021 – Class 2 Recall Over Capsules Failing to Attach

A recall that included Bravo CF product numbers FGS-0635 and FGS-0636 because the capsule might fail to attach and be aspirated. The firm cited 13 aspiration reports over the prior two years.

January 11, 2012 – Class 2 Recall Over Attachment and Detachment Failures

A recall of 21,885 Bravo capsule units for failure to attach to the esophagus or to detach from the placement device.

December 3, 2007 – Earlier Bravo Capsule Recall

A Class 2 recall of 169,365 Bravo capsule and delivery systems sold worldwide because the capsule might not detach from the delivery system after attaching to the esophageal wall.

Talk to a Bravo Capsule Injury Lawyer Today

Fob & Foster Personal Injury Lawyers is based at 2226 1st Ave S, Suite 105, Birmingham, Alabama 35233. We review Medtronic Bravo capsule claims from across the country by phone or video and work alongside national co-counsel who litigate mass tort cases. If you searched for a Bravo capsule lawyer near me after a bad test, you don’t need someone down the street. You need someone who will get the device records and look hard at your dates.

A free review with us is a straightforward conversation. We’ll ask when and where your test was done and what treatment followed, then tell you whether your capsule likely falls under a recall, which deadline probably applies, and what records we need. There’s no fee unless we recover.

Call (205) 407-6009 or toll-free (866) 837-1010, or send us your question online. In some states the deadline is one year, so call sooner rather than later.

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