FDA recall, , Moderate risk
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System
The Insertable Cardiac Monitor System may delay AF Burden Alert notifications, potentially delaying clinical evaluation.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, of Saint Paul, Minnesota, began a recall on August 6, 2026, of the LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System, including server software versions, due to a potential for a delay in AF Burden Alert notification. The delay may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
The recall was added to the FDA's Enforcement Report on September 2, 2026, and classified the same day. Distribution is nationwide in the U.S. and worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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)
- UDI-DI
- 00802526613883
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, Server SW LAT Clarity DS ANZ, Model Number 7248, All Versions (Current 7.7)
- UDI-DI
- 00802526613852
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, Server SW LAT Clarity DS US, Model Number 7260, All Versions (Current 7.8)
- UDI-DI
- 00802526613838
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- Boston Scientific CorporationSaint Paul, Minnesota
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99524
- Recall numbers
- Z-3081-2026 to Z-3083-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
