Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

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:

Product Name	Product Number	UDI-DI
Bravo CF Capsule Delivery Device, 5-pk	FGS-0635	07290101369707
Bravo CF Capsule Delivery Device, 5-pk	FGS-0635	10613994000009
Bravo CF Capsule Delivery Device, 1-pk	FGS-0636	07290101369714

Affected Lot Numbers

Serial Number/Lot Number	Model Number	Description	UDI-DI
62143F	FGS-0635	FGS-0635 CF DELIVERY DEV CAPS BRAVO X5	10613994000009
62880F	FGS-0635	FGS-0635 CF DELIVERY DEV CAPS BRAVO X5	10613994000009
63146F	FGS-0635	FGS-0635 CF DELIVERY DEV CAPS BRAVO X5	10613994000009
63397F	FGS-0635	FGS-0635 CF DELIVERY DEV CAPS BRAVO X5	10613994000009

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.

Reason for Recall

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.

Additional FDA Resources

• FDA Enforcement Report
• CDRH Medical Device Recall Database 

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 recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

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.

Timeline of Communication Updates 

Date	Actions
01/05/2026	The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.
06/24/2025	The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.