Boston Scientific Corporation: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
- Recalling firm
- Boston Scientific Corporation
- Product
- 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)
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/70f4e915-97d7-4efc-b476-8108ba0b4161