Reported May 13, 2026 · Ongoing
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446,…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- 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
- Lot codes and dates
- LUX-Dx II Plus UDI-DI
00802526620706 (US)00802526623707 (EU/AU)
- SERVER SW LATITUDE DRAGON EU UDI-DI00802526613821
- SERVER SW LATITUDE DRAGON AU UDI-DI00802526613814
- Serial Number
148 of 148 codes
100085100676100909100944101811102341102405102864102956102978103018105283105697106372106429106690107386107460108132108429108433108641108697108805108861108901109663109699109836110700110737110858111048111119111269111290111362111780111987112265112549113400113495113720114072114393115310115411115835115862115890115981116066116090116197117180117533117560117820117924
- LUX-Dx II Plus UDI-DI
- Amount recalled
- 148 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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