Medtronic Bravo Capsule Lawsuit

Medtronic and its subsidiary Given Imaging recalled certain Bravo CF capsule delivery devices after discovering that the capsules may fail to attach to the esophagus or detach from the delivery system as intended.

The 2025 recall involved adhesive incorrectly applied during manufacturing, which could interfere with proper capsule deployment.

A separate recall in 2026 addressed a problem with the component responsible for controlling capsule deployment.

These malfunctions can cause serious complications, including esophageal perforation, internal bleeding, aspiration, airway obstruction, retained capsules, and delayed diagnosis.

The FDA classified both recalls as Class I, its most serious recall designation, because continued use of the affected devices could cause serious injury or death.

2026 FDA Class I Medtronic Bravo Capsule Recall

On August 6, 2026, Medtronic initiated a recall of certain Bravo CF capsule delivery devices after identifying a potential defect in the component responsible for controlling capsule deployment.

The FDA issued an early safety alert on August 27, 2026, and classified the recall as Class I on September 15, 2026, indicating that continued use of the affected devices could cause serious injury or death.

According to Medtronic, the defect may prevent the capsule from attaching properly to the esophagus or releasing from the delivery device during a pH monitoring procedure.

The manufacturer also reported that failure to keep the delivery device straight, as instructed in its user guide, could worsen the deployment problem.

As of August 10, 2026, Medtronic had reported 184 serious injuries and no deaths associated with the malfunction.

Medtronic instructed healthcare facilities to identify and quarantine unused affected devices, return recalled products for replacement, and notify other facilities that may have received the devices.

2025 Medtronic Bravo Capsule Recall

On June 3, 2025, Medtronic and its subsidiary Given Imaging initiated a recall of certain Bravo CF capsule delivery devices after identifying a manufacturing defect involving improperly applied adhesive.

The adhesive could prevent the pH monitoring capsule from attaching to a patient’s esophagus or releasing from the delivery device as intended.

The recall affected specific lots of the Bravo CF capsule delivery device, including the five-pack model FGS-0635 and single-pack model FGS-0636.

Medtronic issued an updated recall notice to healthcare facilities on June 16, 2025, and the FDA published an early safety alert on June 24, 2025.

The FDA subsequently classified the recall as Class I on January 5, 2026, its most serious recall designation.

Potential complications included esophageal perforation, lacerations, internal bleeding, aspiration, airway obstruction, retained foreign objects, and delayed diagnosis.

According to the FDA, Medtronic reported 33 serious injuries and no deaths associated with the manufacturing defect.

Healthcare facilities were instructed to identify and quarantine affected devices, return unused recalled products to Medtronic, and notify other facilities that may have received the recalled inventory.

Which Medtronic Bravo Capsules and Lot Numbers Were Recalled?

The 2025 and 2026 Medtronic Bravo capsule recalls affected specific lots of the Bravo CF capsule delivery device manufactured by Given Imaging, a Medtronic subsidiary.

According to the FDA’s recall records, the affected products include:

• Bravo CF Capsule Delivery Device, 5-pack (FGS-0635): Affected by both the 2025 and 2026 recalls.
• Bravo CF Capsule Delivery Device, 1-pack (FGS-0636): Affected by both recalls.
• 2026 recalled lots: Specific lot numbers ranging from 64553F through 68912F, with expiration dates on or before October 20, 2027.
• 2025 recalled lots: Numerous individually identified lots, including 61164F, 62143F, 62880F, 63146F, 63397F, and 65088F. These examples do not represent the complete recall list.

Patients and healthcare providers can review the FDA’s complete 2026 lot number list and the 2025 recall database to determine whether a specific device was affected.

Lot numbers and expiration dates appear on device packaging, although patients who underwent Bravo capsule testing may not have access to that information.

Patients concerned about a recalled device can request their endoscopy records and ask the medical facility to identify the device model, lot number, and expiration date used during their procedure.

A patient’s device may have been affected by a recall even if they did not receive a recall notification directly from Medtronic.

The Medtronic Bravo capsule is a small, wireless medical device used to measure acid levels in the esophagus and help doctors diagnose gastroesophageal reflux disease (GERD).

During an upper endoscopy, a healthcare provider uses the Bravo CF capsule delivery device to position the capsule against the lining of the lower esophagus.

The delivery system attaches the capsule to the esophageal wall and releases it so the placement instrument can be removed.

Once attached, the capsule measures esophageal pH levels and wirelessly transmits the readings to a portable recorder worn by the patient.

Patients use the recorder to document symptoms, meals, and other activities, allowing their healthcare provider to compare reported symptoms with episodes of acid reflux.

The system can collect pH monitoring data for up to 96 hours, after which the capsule eventually detaches from the esophageal lining and passes naturally through the digestive tract.

Unlike traditional catheter-based pH monitoring, the Bravo system allows patients to continue most normal daily activities without a tube remaining in their nose or throat throughout the testing period.

How Can the Bravo Capsule Delivery Device Malfunction?

The Bravo CF capsule delivery device is designed to attach a wireless pH monitoring capsule to the esophageal lining and release it from the placement instrument.

According to the FDA, certain recalled devices may fail to attach the capsule properly or release it from the delivery system during an endoscopy.

The 2025 recall involved improperly applied adhesive during manufacturing, while the 2026 recall identified a potential problem with the component controlling capsule deployment.

If the capsule remains attached to the delivery instrument during removal, it may cause esophageal lacerations, perforation, or internal bleeding.

A capsule that fails to attach properly may also become a foreign object in the esophagus or airway, creating risks of aspiration, airway obstruction, and additional medical procedures.

Deployment failures can prevent successful pH monitoring, potentially requiring repeat testing and delaying the diagnosis of acid reflux or related conditions.

Recipients of Medtronic’s recall notices, including healthcare facilities and distributors, were instructed to identify affected devices, remove them from use, and return unused recalled products to the manufacturer.

Medtronic’s 2025 and 2026 Bravo CF capsule recalls followed reports of device malfunctions that could cause serious injuries during gastroenterology procedures.

The Bravo system is used to monitor acid levels in the esophagus, primarily to help diagnose gastroesophageal reflux disease (GERD).

Adults undergoing Bravo capsule testing may suffer complications if the capsule fails to attach to the esophagus or release from the delivery instrument as intended.

The FDA reported 33 serious injuries associated with the 2025 recall and 184 serious injuries associated with the separate 2026 recall as of August 10, 2026, with no deaths reported in either recall notice.

These malfunctions can damage esophageal tissue, interfere with capsule placement, and require additional medical intervention.

According to the FDA’s recall notices, potential injuries and complications include:

• Esophageal perforation: A tear or hole in the esophageal wall that can allow digestive contents to leak into surrounding tissues, potentially causing severe infections and requiring emergency surgery.
• Esophageal lacerations: Cuts or tears in the esophageal lining caused by improper capsule deployment or removal, potentially resulting in pain, bleeding, and difficulty swallowing.
• Hemorrhage and internal bleeding: Damage to blood vessels or esophageal tissue that can cause significant blood loss and require endoscopic treatment, hospitalization, or blood transfusions.
• Capsule aspiration: A capsule that enters the airway instead of remaining in the digestive tract can cause coughing, choking, breathing difficulties, and potentially serious lung complications.
• Airway obstruction: A displaced capsule may partially or completely block the airway, creating a medical emergency that requires immediate intervention.
• Retained foreign objects: A capsule that fails to deploy or pass through the digestive tract as intended may remain in an unintended location and require additional endoscopic procedures or surgical removal.
• Delayed diagnosis: Failed capsule placement or incomplete pH monitoring can produce insufficient diagnostic information, requiring repeat testing and potentially delaying treatment for GERD or other esophageal conditions.

Patients who suffered injuries during a Bravo CF capsule procedure may qualify to file a Medtronic Bravo Capsule lawsuit if a defective delivery device contributed to their injuries.

Potential claims involve patients whose capsules failed to attach to the esophagus or release from the delivery instrument as intended.

Individuals who experienced esophageal perforation, lacerations, internal bleeding, aspiration, airway obstruction, or other serious complications may have grounds for legal action.

Patients who underwent Bravo capsule testing in 2025 or 2026 may be eligible even if they do not know whether their device was included in either recall.

Medical records, endoscopy reports, device identification information, and documentation of additional treatment can help establish whether a recalled or defective product was involved.

Eligibility depends on the circumstances of the device malfunction, the severity of the injuries, available evidence, and applicable state law.

TorHoerman Law is reviewing potential Medtronic Bravo capsule injury claims and offers free consultations to patients and families seeking to understand their legal options.

Evidence in a Bravo Capsule Injury Claim

Medical records and device identification information can help establish whether a defective Bravo CF capsule delivery device caused or contributed to a patient’s injuries.

Patients may not have access to the device’s packaging or lot number, but the healthcare facility that performed the procedure may have records identifying the equipment used.

Evidence that may support a Medtronic Bravo Capsule lawsuit includes:

• Endoscopy reports: Records of the capsule placement, device malfunctions, and complications during the procedure.
• Device records: Model numbers, lot numbers, and hospital inventory records identifying the device used.
• Medical records: Documentation of injuries, hospitalizations, surgeries, and follow-up treatment.
• Diagnostic imaging: X-rays or CT scans showing perforations, retained capsules, or other complications.
• Medical bills: Records of treatment expenses and other injury-related costs.
• Employment records: Documentation of lost wages or reduced earning capacity.
• Patient communications: Recall notices, provider correspondence, and records of symptoms following the procedure.

Potential Compensation in a Bravo Capsule Lawsuit

Patients injured by defective Medtronic Bravo capsule delivery devices may be entitled to compensation for financial losses and the physical and emotional consequences of their injuries.

A product liability lawyer can assess potential damages by reviewing medical records, treatment expenses, lost income, and the long-term effects of the injury.

The amount of compensation available depends on the severity of the injuries, the extent of the patient’s losses, and applicable state law.

Potential damages in a Medtronic Bravo Capsule lawsuit include:

• Medical expenses: Emergency treatment, hospitalization, surgery, medication, and follow-up care.
• Future medical costs: Ongoing treatment, rehabilitation, and care for lasting complications.
• Lost wages: Income lost while recovering from injuries or undergoing treatment.
• Reduced earning capacity: Loss of future income due to permanent injuries or work limitations.
• Pain and suffering: Physical pain, discomfort, and reduced quality of life.
• Emotional distress: Anxiety, psychological trauma, and other emotional consequences of the injuries.
• Wrongful death damages: Funeral expenses, lost financial support, and other applicable losses if a device-related injury results in death.

TorHoerman Law is investigating potential product liability claims involving defective Medtronic Bravo CF capsule delivery devices.

Patients who suffered esophageal perforations, internal bleeding, aspiration, or other serious complications during Bravo capsule procedures may have grounds to pursue compensation for their injuries.

Our law firm is reviewing cases involving the 2025 and 2026 recalls, including claims from patients who do not know whether their device was included in the affected lots.

Medical records, procedure reports, and device identification information may help determine whether a manufacturing defect contributed to a patient’s injuries.

If you or a loved one experienced complications during a Medtronic Bravo capsule procedure, contact TorHoerman Law for a free, no-obligation consultation.

You can also use our online chat feature to discuss your experience and learn more about your legal options.