LUX-Dx II Plus — Class II medical device recall Z-2049-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-05-13, distributed nationwide. For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not co
| Recall number | Z-2049-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2026-03-30 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE |
| Quantity | 148 units |
| UPC / GTIN / UDI-DI | 00802526613814, 00802526613821, 00802526620706, 00802526623707 |
| Serial numbers | 100085, 100676, 100909, 100944, 101811, 102341, 102405, 102864, 102956, 102978, 103018, 105283, 105697, 106372, 106429, 106690, 107386, 107460, 108132, 108429, 108433, 108641, 108697, 108805, 108861 and 123 more |
| Model numbers | 6446, 6448, M312 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2049-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.