Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Medtronic and their subsidiary Given Imaging Inc. have issued two letters to affected customers recommending certain Bravo CF Capsule Delivery Devices be removed from where they are used and sold:

What to Do

Immediately identify and quarantine all affected Bravo CF capsule delivery devices.

On June 3, 2025, Medtronic sent all affected customers an “URGENT: MEDICAL DEVICE RECALL” letter. An updated letter was sent on June 16, 2025. Medtronic recommends the following actions:

• Immediately identify and quarantine all affected lots of unused FGS-0635 (Bravo CF capsule delivery device, 5-pk) and FGS-0636 (Bravo CF capsule delivery device, 1-pk). Note that the Lot numbers linked in the Affected Product section above can be found on both the 5-pk FGS-0635 outer label and on the 1-pk FGS-036 individual units. Customers should check the full list of Lot numbers listed in the linked file when inspecting inventory. Example product labels: 

• Return all unused, affected products to Medtronic for replacement or credit as described on the Customer Confirmation Form. 
• Pass on this notice to all those who need to be aware within your organization or to any organization where the affected product has been transferred or distributed.
• Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Medtronic has stated that the capsule may not attach to the patient’s esophagus or detach from the delivery device as intended due to a misapplication of adhesive during manufacturing of the Bravo CF capsule delivery device. Risks associated with this issue include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Medtronic has reported 33 serious injuries and no deaths associated with this issue.

Device Use

The Bravo system is designed to place and attach a pH monitoring capsule to the esophagus that records pH data to assist a physician in diagnosing clinical gastroesophageal reflux. The Bravo system involves the placement of a pH capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a recorder attached to the patient’s waist. The patient interacts with the recorder to indicate symptoms, allowing the physician to compare the patients’ symptoms to the occurrence of the reflux episodes.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medtronic at 800-448-3644, Option 3.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.