Boston Scientific Corporation: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

Tags

FDA recall, medical device, class 2, Cardiovascular, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 4: Incident Management

Source record id

Z-3082-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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