Documentary record · DEVICE EARLY ALERT
FDA Early Alert: Bravo CF esophageal pH-monitoring capsule delivery devices may fail to attach or detach
Event date
August 27, 2026
Jurisdiction
United States
Issuing body
U.S. Food and Drug Administration
Action type
DEVICE EARLY ALERT
Lifecycle state
EARLY ALERT — REMOVAL RECOMMENDED BY MANUFACTURER
Verification date
15 September 2026
Legal effect
An FDA Early Alert publicising a manufacturer’s removal recommendation. It is not a final recall classification and creates no new legal duty for clinicians; it tells users which lots to quarantine and return.
What this establishes
- Medtronic and its subsidiary Given Imaging told affected customers on 6 August 2026 to quarantine and return certain Bravo CF capsule delivery devices.
- The capsule may fail to attach to the esophagus or to detach from the delivery device. FDA lists risks including aspiration, esophageal perforation or laceration, airway obstruction, bleeding, delayed diagnosis and retained foreign body.
- As of 10 August 2026 the manufacturer had reported 184 serious injuries and no deaths. Affected lots carry expiration dates on or before 20 October 2027; lots expiring 10 December 2027 or later are out of scope.
- A subset of lots was in a June 2025 recall; the failure is the same but the underlying cause is different.
What this does not establish
- A final FDA recall classification for this action.
- That pH monitoring with a correctly functioning device is unsafe.
- Any finding about an individual patient’s procedure.
Why it matters
Wireless pH monitoring is an outpatient diagnostic step in reflux evaluation. The alert is a reminder that device-surveillance information reaches clinicians in stages — customer letter, Early Alert, classification — and each stage means something different.
Primary source
Related on this site
Register: the record store · record id fda-bravo-cf-early-alert-2026-08-27.