Boston Scientific LUX-Dx Insertable Cardiac Monitor Recall Over AF Burden Alert Delay
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Boston Scientific is recalling LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor systems due to potential delays in AF Burden Alert notifications.
The full picture behind this FDA recall
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.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Boston Scientific Corporation is recalling certain Insertable Cardiac Monitor systems because there is potential for a delay in AF Burden Alert notification affecting the server software. Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
Which Products Are Affected
The recall affects LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7). The UDI-DI is 00802526613852. Distribution is US Nationwide and worldwide. The recall number is Z-3083-2026.
What You Should Do
Consumers and healthcare providers should follow instructions provided by Boston Scientific Corporation regarding the affected devices. Contact information for returns or further guidance is available through the recalling firm.
Why This Matters
This Class II recall involves a potential delay in notifications for atrial arrhythmias that could affect clinical evaluation or intervention.
Source
FDA Recall Z-3083-2026 - Boston Scientific Corporation, Saint Paul, MN
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,153 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.