Recall Z-3081-2026 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Boston Scientific Corporation
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)
| Date | Sep 2, 2026 (initiated Aug 6, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction dated August 2026 was sent to customers. Boston Scientific is notifying you of the potential for a delay in AF Burden Alert notification affecting the LATITUDE" Clarity server software which supports the LUX-Dx" family of ICMs. This delayed AF Burden Alert notification behavior by LATITUDE Clarity may occur if the Alert for AF Burden e Threshold is configured to ">0 hours per day" setting (a non-default configuration). The ICM is performing as intended with continued AF detection, data storage, and transmission of device data. Boston Scientific has received |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) Boston Scientific Corp, Aug 19, 2023 |