Medtronic has issued its second recall in two years for its Bravo CF pH monitoring capsules, this time affecting devices linked to 184 serious injuries, the Food and Drug Administration (FDA) announced Thursday. The recall, which the FDA communicated in an early alert notice, affects Bravo CF capsules that pose risks including perforation of the esophagus, obstruction of the airway, and blood loss.
Understanding the Recall: Deployment Component Failure
The recall involves Bravo CF capsules that may fail to attach to the patient’ esophagus or detach from the delivery device as intended. This failure is due to a problem with the component that controls the deployment of the capsule. The company stated that this issue is exacerbated when the healthcare professional does not keep the delivery device straight, as instructed in the user guide.
Medtronic identified the same failures as the trigger for both recalls, but the underlying causes of the issues were different. Last year, the company recalled a subset of the newly affected lots due to a manufacturing defect related to the delivery device’s adhesive. In this latest recall, the problem lies with the deployment component of the capsule, which is responsible for securely attaching and detaching the capsule as required.
Potential Complications: Laceration, Delayed Diagnosis, Foreign Bodies
The attachment and detachment failures of the Bravo CF capsules pose a range of risks. The FDA named laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient among the potential harms associated with the recall. Laceration of the esophagus can lead to severe bleeding and infection, while a delay in diagnosis may result in improper or delayed treatment. Foreign bodies left in the patient can cause discomfort, pain, and may require additional surgical procedures for removal.
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As of August 10, Medtronic had received reports of 184 serious injuries and no deaths associated with the issue.
Recalled Devices and Next Steps: Medtronic’s Response
Bravo CF capsules with an expiration date on or after December 10, 2027, are not affected by the recall. Medtronic has advised customers to identify, quarantine, and return all unused affected devices. The company has taken prompt action to address the issue and minimize potential impact on patients, demonstrating its commitment to patient safety.
Medtronic acquired Given Imaging, the original manufacturer of the Bravo system, in 2014 for about $860 million. The company continues to sell the device through its Given Imaging subsidiary.
Healthcare professionals can contact Medtronic’s Product Surveillance team for more information at 1-800-526-6123 or by email at…
