FDA Issues Warning on Medtronic's Bravo CF Capsule Delivery System Linked to 33 Serious Injuries

Jun 28, 2025 11:30 CST Updated 11:30

Medtronic

Medical Device Manufacturer

FDA Releases a Statement on MedtronicGastrointestinal ProductsEarly Warning. This warning includes MedtronicTheBravo CF CapsuleA variety of model delivery systems,Its intended use:WillThe pH monitoring capsule attaches to the esophageal wall, recording pH data to assist doctors in diagnosing gastroesophageal reflux disease.The capsule transmits data to a recorder worn on the patient's waist while measuring esophageal pH levels. Patients can mark symptom time points for doctors to compare the correlation between reflux events and symptoms.

Involved Product

FDA Orders Medtronic to Immediately Cease Use and Remove the Following from ShelvesBravo CF CapsuleDelivery System.

Reason for Warning

Medtronic in productionBravo CF CapsuleImproper use of adhesive during the delivery system process,pH Monitoring CapsuleMay not attach to the esophagus as expected or may detach from the delivery device, potentially leading to the following risks:

Patient Aspiration/Inhalation
Esophageal Perforation
Airway Obstruction
Bleeding/Hemorrhage
Esophageal Laceration
Delayed Diagnosis
Residual Foreign Bodies in the Body

Currently, there have been 33 serious injury incidents, with no fatalities reported.

Medtronic Initial Measures

Immediately identify and quarantine all unused products from the affected batches (FGS-0635 five-pack/FGS-0636 single-pack).

Batch Number Labeling Location: FGS-0635 outer packaging label and FGS-0636 single-unit product (for batch number verification, refer to the complete list in the original link)

Product Label Example:

Return the unused involved products to Medtronic for replacement or refund as required by the Customer Confirmation Form.