FDA Sounds Alarm After 33 Injuries Tied To Medtronic Device Malfunction

The U.S. Food and Drug Administration (FDA) is aware that Medtronic Plc (NYSE:MDT) and its subsidiary, Given Imaging Inc., have issued two letters to affected customers recommending that certain Bravo CF Capsule Delivery Devices be removed from where they are used and sold.

What Happened: Earlier in June, Medtronic sent all affected customers an "URGENT: MEDICAL DEVICE RECALL" letter. An updated letter was sent on June 16.

Medtronic on Tuesday stated that the capsule may not attach to the patient's esophagus or detach from the delivery device as intended due to a misapplication of the adhesive during manufacturing the Bravo CF capsule delivery device.

Risks associated with this issue include patient aspiration/inhalation, perforation of the esophagus, airway obstruction, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

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