FDAFDA recall Z-3082-2026 · Sep 9, 2026
Boston Scientific Corporation: LUX-Dx recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00802526613883
- Quantity
- N/A
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-06
Source: openFDA enforcement record Z-3082-2026 · search recall number Z-3082-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.