Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging

Medtronic and Given Imaging's Bravo CF esophageal pH monitoring capsule could fail to attach to the esophagus or detach from its delivery device, resulting in serious patient safety risks. The FDA advises immediate identification, quarantine, and return of affected devices.

What changed: The FDA has issued an Early Alert to notify about the failure of Bravo CF esophageal pH monitoring capsule delivery devices that may not attach properly, potentially leading to severe patient risks.

Why it matters: Failures in the device can lead to serious injuries including aspiration, perforation, obstruction, hemorrhage, and delays in diagnosis, with 184 serious injuries reported as of August 10, 2026.

Practical implication: Customers must immediately identify and quarantine all unused affected devices (Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636) and return them to Medtronic for replacement.

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• Source: FDA - Medical Device Safety
• Published at source: 2026-08-27T14:54:22.000Z
• Discovered by monitor: 2026-08-27T22:09:01.747Z

Published from the regulator source ingestion pipeline after PV impact triage.