What was recalled and why?

Boston Scientific Corporation recalled 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. FDA's record states the reason for recall as: 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.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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) and recall number Z-2049-2026, then follow Boston Scientific Corporation's recall instructions.

Has Boston Scientific Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation, including 6 recalls and 0 warning letters.

FDA Class II Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model… by Boston Scientific Corporation

Key facts

Recalling firm	Boston Scientific Corporation
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	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
Classification	Class II
Recall number	Z-2049-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
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.

In short: Boston Scientific Corporation recalled 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 on 2026-05-13. FDA classified this action as a Class II recall (recall number Z-2049-2026). 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 (additional items listed in FDA's full record). Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Boston Scientific Corporation and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2049-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number Z-2049-2026. If it matches, stop using or distributing it and contact Boston Scientific Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Boston Scientific Corporation’s FDA history

Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Boston Scientific Corporation recalled 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. FDA's record states the reason for recall as: 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.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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) and recall number Z-2049-2026, then follow Boston Scientific Corporation's recall instructions.
Has Boston Scientific Corporation had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation, including 6 recalls and 0 warning letters.

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Full FDA history for Boston Scientific Corporation

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model… by Boston Scientific Corporation — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-boston-scientific-corporation-z-2049-2026

MLA

"FDA Class II Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model… by Boston Scientific Corporation — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-boston-scientific-corporation-z-2049-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model… by Boston Scientific Corporation — Recall Details." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-boston-scientific-corporation-z-2049-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_boston_scientific_corporation_z_2049_2026_2026,
  title = {FDA Class II Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model… by Boston Scientific Corporation — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-boston-scientific-corporation-z-2049-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗