Medtronic has recalled Bravo capsule delivery devices due to product malfunctions that have been tied to 33 serious injuries, according to an early alert published Tuesday by the Food and Drug Administration.
Medtronic, along with its subsidiary Given Imaging, has asked customers to identify and quarantine all affected devices and return all unused items. The devices have been recalled because the capsule may not attach to a patient’s esophagus or detach from the delivery device due to a manufacturing problem.
Medtronic sent a recall letter to customers on June 3 and an updated letter on June 16, according to the alert. There have been no deaths associated with the recall.
Bravo capsule delivery devices are designed to place and attach a pH monitoring capsule to a patient’s esophagus to record pH data and assist in diagnosing acid reflux. The capsule transmits data to a recorder that is attached to the patient's waist.
Risks associated with the manufacturing problem include patient aspiration/inhalation, obstruction of the airway, perforation of the esophagus, hemorrhage/blood loss/bleeding and laceration of the esophagus, among others. There is also a risk of foreign bodies remaining in the patient.
