Recall Z-2049-2026 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Boston Scientific Corporation
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
| Date | May 1, 2026 (initiated Mar 30, 2026) |
| Status | Open, Classified |
| Reason | For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location. |
| Root cause | Under Investigation by firm |
| Action | An IMPORTANT Medical Device Correction notification letter dated 3/30/26 was sent to customers. Recommendations As noted previously, Boston Scientific released an update to LATITUDE Clarity on March 27, 2026 to correct this programming discrepancy. Devices impacted by this issue will be automatically corrected to the clinician assigned programming once the device successfully reconnects with LATITUDE Clarity. To confirm updated programming settings have been applied to the impacted M302/M312 device: " Navigate to the patient s profile on LATITUDE Clarity; " Verify that the last connection to |
| Quantity | 148 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Belgium. |
| 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 |