Medtronic Intensifies Recall Efforts Amid High-Risk Bravo CF Capsule Delivery System Issues

Source: Medical Device Business Review

Recently, the FDA issued a notice stating thatMedtronic Recalls Bravo CF Capsule Delivery Device Due to High-Risk Equipment Issues

The Bravo system is designed to place and secure a pH monitoring capsule within the esophagus to assist physicians in diagnosing gastroesophageal reflux disease (GERD) by continuously recording pH data. The system secures the pH capsule to the esophageal mucosal wall, simultaneously enabling pH monitoring and data transmission. Monitoring data can be transmitted in real time to a recording device worn around the patient’s waist. Patients can actively mark the onset of symptoms via the recording device, allowing physicians to compare the correlation between patient-reported symptoms and actual reflux events, thereby aiding clinical diagnostic decisions.

Bravo CF Capsule System

Medtronic stated that the improper use of adhesive during the manufacturing process of the Bravo CF Capsule Delivery SystemThe capsule may fail to adhere to the patient's esophagus as intended or detach from the delivery device.

The risks associated with this issue include patient aspiration, esophageal perforation, airway obstruction, bleeding/hemorrhage, esophageal tearing, delayed diagnosis, and retention of foreign objects within the patient.

Medtronic has reported 33 serious injury incidents related to this issue, with no deaths.

On June 3, 2025, Medtronic sent an "Urgent: Medical Device Recall" letter to all affected customers. An updated letter was issued on June 16, 2025, recommending the following actions:

• Immediately identify and quarantine all unused affected batches of FGS-0635 (Bravo CF Capsule Delivery Device, 5-pack) and FGS-0636 (Bravo CF Capsule Delivery Device, 1-pack).Please note that the batch numbers linked in the "Affected Products" section above can be found on the FGS-0635 outer label of the 5-pack and on individual FGS-036 products in the 1-pack. Example of product label:

• Return all unused, affected products to Medtronic and follow the instructions on the customer confirmation form for replacement or refund.

• Forward this notice to all personnel within your organization who need to be informed, or to any organization to which the affected products have been transferred or distributed.

• Please check this webpage for the latest information. The FDA is currently reviewing the information regarding this potential high-risk device issue and will promptly inform the public when there are significant new updates.