Boston Scientific LUX-Dx II Plus Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Corporation is recalling 148 units of LUX-Dx II Plus arrhythmia detectors due to data collection failures after device upgrades.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Boston Scientific Corporation initiated a voluntary recall of certain LUX-Dx II Plus devices because, 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.
Which Products Are Affected
The recall affects LUX-Dx II Plus, Arrhythmia 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. A total of 148 units are affected. The recall number is Z-2049-2026. Distribution was to US Nationwide and Belgium. UDI-DI numbers include 00802526620706 (US) and 00802526623707 (EU/AU).
What You Should Do
Affected patients and healthcare providers should follow guidance from Boston Scientific Corporation regarding the recalled devices.
Why This Matters
The recall involves 148 units distributed nationwide in the United States and in Belgium, classified as Class II by the FDA.
Source
FDA Recall Z-2049-2026 - Boston Scientific Corporation, Saint Paul, MN
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,313 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.