Has Boston Scientific Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 292 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 292 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-09; Argus observed and indexed it on 2026-09-15.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Boston Scientific Corporation — Class II recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2026-09-09
License: https://argushq.ai/methodology

Event date: 2026-09-09 00:00:00Z
Observed: 2026-09-15 04:20:31Z
Source ID: Z-3082-2026
Payload hash: 82f49e77c27d3dc2e8de482c…

Summary

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia. Status: Ongoing.

Entities

Boston Scientific Corporation

View source record ↗

Frequently asked questions

Has Boston Scientific Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 292 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 292 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-09; Argus observed and indexed it on 2026-09-15.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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). Boston Scientific Corporation — Class II recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-3082-2026

MLA

"Boston Scientific Corporation — Class II recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-boston-scientific-corporation-z-3082-2026.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class II recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C…." Digital Empire Holdings LLC. Accessed September 15, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-3082-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_3082_2026_2026,
  title = {Boston Scientific Corporation — Class II recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT C…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-3082-2026},
  note = {Accessed: September 15, 2026}
}

Informational only. Not legal, financial, or medical advice.