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Medtronic Recalls Defective Bravo Capsule Delivery Devices Due to Risk of Internal Injuries


WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued an early warning regarding a recall of Medtronic’s Bravo capsule delivery devices, citing a risk of serious injury tied to device malfunctions. According to the alert, 33 injuries have been reported.

Medtronic and its subsidiary, Given Imaging, initiated the recall after discovering that the capsule may fail to properly attach to the patient’s esophagus or may not detach correctly from the delivery system due to a manufacturing defect.

The Bravo capsule system is used to attach a pH monitoring device to a patient’s esophagus for the diagnosis of gastroesophageal reflux disease (GERD), also known as acid reflux. The capsule wirelessly transmits data to an external recorder worn by the patient. If the device malfunctions, patients may face significant complications, including airway obstruction, esophageal perforation, bleeding, and other internal injuries. In rare cases, there is a risk that the capsule may become a retained foreign object.

Contact The Ammons Law Firm for Legal Help Involving Defective Products

Contact The Ammons Law Firm today for a free consultation to discuss your case and learn more about your legal options. You may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages caused by this defective product.

 

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