FDA Classifies Medtronic Bravo CF Capsule Delivery Device Removal as Class I Recall

The Food and Drug Administration has classified Medtronic's removal of certain Bravo CF capsule delivery devices, used to place a pH monitoring capsule in the esophagus during reflux testing, as a Class I recall, the agency said in an update to its notice on September 15.

The FDA first flagged the problem in an early alert on August 27. Its updated notice says Medtronic and its subsidiary Given Imaging, Inc. sent affected customers a letter on August 6, 2026 recommending that the devices be removed from where they are used or sold.

The devices and the reported failure

The recall covers the Bravo CF capsule delivery device in a five-pack (product number FGS-0635) and a one-pack (FGS-0636), in lots with expiration dates up to and including October 20, 2027. Lots expiring on December 10, 2027 or later are outside the recall, according to the FDA. The agency's recall database entry, numbered Z-3090-2026, lists Given Imaging Ltd. in Yokne'am Ilit, Israel, as the recalling firm, 127,416 units in commerce, and distribution across the United States, Puerto Rico and more than 35 other countries.

Medtronic stated that the capsule may not attach to the patient's esophagus or detach from the delivery device as intended, and that the failures may be due to a problem with the component that controls deployment of the capsule. The company said the problem can be made worse if the delivery device is not kept straight as the user guide instructs. The FDA's database entry lists the cause as nonconforming material or component.

The FDA lists the associated risks as aspiration or inhalation, perforation of the esophagus, airway obstruction, bleeding, laceration of the esophagus, delayed diagnosis and foreign bodies remaining in the patient. As of August 10, 2026, Medtronic had reported 184 serious injuries and no deaths associated with the issue, according to the agency.

A repeat of the 2025 failure

Medtronic stated that a subset of the affected lots was included in a recall notice sent to customers and distributors in June 2025. The FDA said the failure in the new recall is the same as in the earlier one, but the underlying cause is different.

When the June 2025 recall was announced, Medtronic had received reports of 33 serious injuries, MedTech Dive reported at the time. In its August 28 report on the new recall, the outlet said the earlier fault stemmed from misapplied adhesive during manufacturing of the delivery device rather than from the deployment component. MedTech Dive also noted that Medtronic sells the Bravo system through Given Imaging, which Covidien, now part of Medtronic, acquired in 2014.

The FDA notice tells customers not to use affected delivery devices and to quarantine them until they can be returned to Medtronic for replacement. Medtronic's letter also asked customers to pass the notice on within their organizations and to any organization that received affected products. According to the database entry, customers were asked to return a response form to the company even if they hold no unused affected inventory.

The Bravo system places a capsule against the wall of the esophagus that measures pH and transmits the data to a recorder worn at the patient's waist, helping physicians diagnose gastroesophageal reflux, the FDA said.