# FDA recall Z-3082-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2026-08-06.

## Product

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)

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-3082-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-06
- **Report date:** 2026-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3082-2026

## Citation

> AI Analytics. FDA recall Z-3082-2026. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-3082-2026. Source: US FDA. Licensed CC0.

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