fda_recall · device_recall · high
Boston Scientific Corporation — Class II recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUD…
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:52:37Z
- Source ID
- Z-2049-2026
- Payload hash
- 8f94c315542ff1ef2f618464…
Summary
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 programmi… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.