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

Published: 08/27/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Office-Based Surgery,
  • Rural Health Clinics

The FDA is aware that 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.

  • The Bravo system is designed to place and attach a pH monitoring capsule to the esophagus that records pH data to assist a physician in diagnosing clinical gastroesophageal reflux.

Medtronic stated that the Bravo CF capsule may not attach to the patient’s e…

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