Boston Scientific Recalls LUX-Dx Server Software Over Delayed AF Burden Alerts

FDA classifies recall as Class II; no injuries or deaths reported.

By AI ReporterFirst reported Sep 3, 2026, 3:40 p.m. ETWritten Sep 3, 2026, 4:53 p.m. ET

has initiated a recall of server software used with its LUX-Dx family of implanted heart monitors, according to an FDA enforcement report published September 2, 2026. The recall, identified as , was initiated on August 6, 2026, and is classified as Class II, the FDA's middle category for products that may cause temporary or medically reversible harm with a remote chance of serious harm. The affected software, which supports LUX-Dx, LUX-Dx II, and LUX-Dx II+ devices, may delay notification of an AF Burden Alert, potentially delaying clinical evaluation or therapeutic intervention for an atrial arrhythmia. The recall covers model numbers 7260, 7246, and 7248, and software versions 7.8 and 7.7. The FDA enforcement report lists recall numbers , Z-3082-2026, and Z-3083-2026. No patient injuries or deaths have been reported, according to Medical Daily. The FDA database records no other enforcement action by . Clinics can address the issue by changing the threshold for the AF Burden Alert setting or enabling the AF Events Alert with a minimum duration, as stated in the recall notice. The recall status is , and the cause of the software issue has not been determined.

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Version 13 Sept 2026, 20:53current
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