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Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic
The FDA is aware that Medtronic and its 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.
Medtronic has stated that the capsule may not attach to the patient’s esophagus or may not 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.
At this time, Medtronic has reported 33 serious injuries and no deaths related to this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medtronic at 800-448-3644, Option 3.
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