FDAAugust 6, 2026
Boston Scientific LUX-Dx Insertable Cardiac Monitor Recall Over Delayed AF Burden Alert
FDA published this notice on August 6, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- August 6, 2026
- Recall class
- Class II
- Reason given by the agency
- 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.
- Official source
- the notice at its source
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Source: FDA.