{"url_path":"/fda/device/recalls/Z-2048-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-30","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2048-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Boston Scientific Corporation"},"word_count":152,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2048-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-30\n**Report date:** 2026-05-13\n\n## Product\nLUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5\n\n## Reason\nFor 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.\n\n## Affected lots\nLUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787\n\n## Distribution\nWorldwide distribution - US Nationwide and the country of Belgium."}