Medtronic recalls Bravo CF reflux monitoring capsule after 184 serious injuries reported

Medtronic has issued a recall of its Bravo CF esophageal pH monitoring capsule, a wireless device used to assess acid reflux. The recall follows an FDA early alert after the company identified a problem with the capsule’s deployment.

The device is attached to the esophagus during an endoscopy and is intended to detach after several days, passing naturally through the digestive tract. Medtronic found that the capsule may fail to attach properly or may not detach from the delivery system as designed.

The malfunction can lead to serious complications such as bleeding, airway blockage, or tissue lacerations. As of August 10, the company reported 184 serious injuries linked to the issue, though no deaths have been recorded.

Medtronic sent a notification to customers on August 6 and the FDA has issued an early alert. The company advises users to follow the delivery device straightening instructions in the user guide to reduce risk.