Key Takeaway:
- FDA flags the Medtronic Esophageal Monitoring Device after 184 serious injuries linked to capsule deployment failures.
- Potential risks include aspiration, esophageal perforation, bleeding, and airway obstruction.
- Medtronic urges facilities to stop using affected devices, quarantine them, and return them for replacement.
The FDA issued an early alert Aug. 27 for certain Medtronic Bravo CF devices after 184 serious injuries linked to failures that can cause the capsule to detach improperly.
FDA Warns Of Potentially High-Risk Device Failure
The U.S. Food and Drug Administration said the affected Bravo CF capsule delivery devices used with the Medtronic Esophageal Monitoring Device may fail to attach to a patient’s esophagus or detach from the delivery device as intended. The agency classified the issue as potentially high risk and said it is continuing to review the matter.
Medtronic, through its subsidiary Given Imaging, notified affected customers and recommended removing certain devices from use or sale. The affected products include Bravo CF capsule delivery devices sold in one-pack and five-pack configurations. Lots with expiration dates on or before Oct. 20, 2027, are included in the alert.
“Do not use affected delivery devices,” the FDA said, directing health care facilities to immediately identify and quarantine the products until they can be returned to Medtronic for replacement.
The FDA said Medtronic reported 184 serious injuries and no deaths associated with the issue as of Aug. 10. The reported injuries raise concerns because the Medtronic Esophageal Monitoring Device is used during testing to help physicians diagnose gastroesophageal reflux.
Device Problem Can Cause Serious Complications
Medtronic said the capsule’s deployment problem may stem from a component that controls how the capsule is released. The company also said the problem can worsen if the delivery device is not kept straight as directed in its user guide.
The company told regulators the capsule “may not attach to the patient’s esophagus or detach from the delivery device as intended,” according to the FDA alert.
Potential complications include aspiration or inhalation of the capsule, esophageal perforation, airway obstruction, bleeding, esophageal laceration, delayed diagnosis, and retention of a foreign body, the FDA said.
The Medtronic Esophageal Monitoring Device places a pH-monitoring capsule against the esophageal wall. The capsule records acid levels and transmits information to a recorder worn by the patient, allowing physicians to compare reflux episodes with reported symptoms.
Recall Follows Earlier Device Safety Action
The latest alert involving the Medtronic Esophageal Monitoring Device follows a June 2025 recall involving some of the same lots. Medtronic said the device failure described in the earlier recall is the same, but the underlying cause differs from the issue identified in the current action.
The FDA previously classified a related Bravo CF recall as a Class I recall, its most serious category, after reports that the capsule could fail to attach properly and create risks including aspiration and other serious complications.
Medtronic sent affected customers a letter Aug. 6 recommending that unused devices be identified, quarantined, and returned for replacement. The company also asked customers to notify organizations that may have received or distributed the affected products.
Devices with expiration dates of Dec. 10, 2027, or later are not included in the current action and do not need to be returned, according to the FDA. The agency said it will update its alert as additional information becomes available.
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