FDA MedWatch Safety AlertsOriginal article
Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
RegulatoryBravo CFNegative
AI Analysis
Summary
FDA MedWatch alert issued for Medtronic and Given Imaging's Bravo CF esophageal pH monitoring capsule regarding failures to attach to the esophagus or detach from its delivery device.
Outcome Details
Device delivery and attachment failure alert issued
Importance:6/10
Sentiment:
-0.80
device safetyFDA MedWatch alertproduct qualityesophageal monitoring
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Published by FDA MedWatch Safety Alerts on August 27, 2026 4:00 AM