Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failures
The FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices.
The problem involves the capsule failing to attach to the esophagus or detaching from its delivery system, prompting a safety concern.
Medtronic and its subsidiary Given Imaging sent a letter on August 6, 2026 advising customers to stop using the affected devices, quarantine them, and return them for replacement. The alert covers specific lot numbers with expiration dates up to October 20, 2027; lots expiring after December 10, 2027 are not affected.
Users are instructed to identify and isolate any unused devices and follow the return process outlined by Medtronic, while the FDA will update the public as more information becomes available.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging”
read at fda medwatch ↗
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