Boston Scientific LUX-Dx Insertable Cardiac Monitor Recall Over AF Burden Alert Delay (Aug 6, 2026)
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Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor systems due to potential delays in AF Burden Alert notifications.
FDA recall: what the record actually shows
This notice was issued by FDA on September 16, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed worldwide - us nationwide distribution.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
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.
Which Products Are Affected
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7). UDI-DI: 00802526613883. Distributed worldwide with US Nationwide distribution.
What You Should Do
The recall is voluntary and firm initiated. No specific consumer actions are detailed in the recall notice.
Why This Matters
Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
Source
FDA recall number Z-3082-2026, Boston Scientific Corporation, Saint Paul, MN.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (909 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 16, 2026.
Common Questions
Common questions about this FDA recall.