# FDA recall Z-2049-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2026-03-30.

## Product

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

## Reason for recall

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

## Distribution

Worldwide distribution - US Nationwide and the country of Belgium.

## Key facts

- **Recall number:** Z-2049-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-30
- **Report date:** 2026-05-13

- **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-2049-2026

## Citation

> AI Analytics. FDA recall Z-2049-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2049-2026. Source: US FDA. Licensed CC0.

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