The FDA issued an alert following device manufacturer Medtronic’s announcement recommending that certain Bravo calibration-free capsule delivery devices be quarantined from sale or use. The company sent letters to affected customers in June announcing the recall.

According to the FDA, Medtronic said the capsule, which is designed to aid in the clinical diagnosis of gastroesophageal reflux disease by monitoring pH, “may not attach to the patient’s esophagus or detach from the delivery device” due to a misapplication of adhesive during manufacturing.

Risks associated with this issue include patient inhalation, perforation or laceration of the esophagus, airway obstruction, hemorrhage, and foreign objects remaining in the patient. The company has reported 33 serious injuries and no deaths related to the capsules, the FDA said.

The recall includes single-capsule and five-pack units, and a list of affected serial and lot numbers is available here. Customers should return affected and unused devices to Medtronic for replacement or credit, according to the release.

—GEN Staff