FDA posted a Class I recall on September 15 covering the Bravo CF capsule delivery device, sold by Medtronic and Given Imaging. The device places a wireless pH capsule on the esophageal wall for reflux monitoring. FDA counts 184 serious injuries and no deaths as of August 10.
The problem sits in the component that controls capsule deployment. The capsule can fail to attach to the esophagus, or come off the delivery device before it should. FDA lists aspiration, esophageal perforation, airway obstruction, hemorrhage and delayed diagnosis among the risks.
Two catalog numbers are affected, FGS-0635 and FGS-0636, across all lots with expiration dates on or before October 20, 2027. Medtronic sent notification letters on August 6 and told customers to quarantine unused devices and return them for replacement.
Roughly six weeks passed between Medtronic's letter and the FDA posting, which is ordinary. It is also why a competitive watch built on the FDA recall page always runs late. A deployment mechanism with no redundancy is the failure mode a design FMEA is meant to catch, and 184 injuries is the price when the review misses it.