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Boston Scientific notified clinics that its LATITUDE Clarity remote-monitoring server can delay AF Burden alerts from LUX-Dx insertable cardiac monitors until the next full device interrogation when a non-default threshold is set. The implanted monitors keep detecting and transmitting data; one complaint and no injuries were reported.
TierThe sources document delayed alert notification under one configuration but no change in how care was delivered. How tiers are assigned.
In an August 2026 Urgent Medical Device Correction, Boston Scientific said that when the AF Burden alert threshold is set to '>0 hours per day' (a non-default configuration), the LATITUDE Clarity server does not convert the daily device check into a full device interrogation as intended. Without a full interrogation the system cannot evaluate the alert, so notification of an AF Burden alert may be delayed until the next full interrogation, which is triggered by another alert, a scheduled remote follow-up, or a patient- or clinic-initiated interrogation. The company said the implanted monitor keeps detecting AF, storing data and transmitting device data. Boston Scientific reported one complaint and no patient injuries or deaths, and said a server software update is planned. Until then it advised changing the threshold to another setting or enabling AF Event alerts with a minimum duration such as 2 minutes, and does not recommend replacing implanted monitors. It said delayed notification may delay clinical evaluation or treatment of an atrial arrhythmia, while the most serious consequences remain hypothetical. FDA's recall database lists the correction as Class 2 (Z-3081-2026), initiated 6 August 2026 and posted 2 September 2026, with software design as the cause.[1,2]
None documented (one complaint; no injuries or deaths reported, per Boston Scientific and FDA).
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