On Sept. 15, FDA assigned its most serious recall classification to Medtronic and subsidiary Given Imaging’s removal of certain Bravo CF esophageal pH-monitoring capsule delivery devices. The agency initially issued an early alert Aug. 27, but the Class I classification is new.
The capsule may fail to attach to the esophagus or detach properly from its delivery device. Potential consequences include aspiration, airway obstruction, esophageal perforation or laceration, hemorrhage, retained foreign material, and delayed diagnosis. Medtronic had reported 184 serious injuries and no deaths as of Aug. 10.
Medtronic and their subsidiary Given Imaging, Inc. have issued a letter to affected customers recommending certain esophageal pH monitoring capsule delivery devices be removed from where they are used or sold.
Hospitals should identify and quarantine affected devices, covering listed lots with expiration dates through Oct. 20, 2027, and return unused products to Medtronic for replacement.
Why it matters: The action carries immediate inventory control and patient safety implications for gastroenterology, endoscopy, procedural services, and supply chain teams. The 184 reported injuries also warrant examination of whether hospitals can identify affected lots and patients previously exposed to the devices.
